 |
Guidance Documents
Guidance documents represent the Agency's current thinking on a particular
subject. They do not create or confer any rights for or on any person and do not
operate to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute, regulations, or
both. For information on a specific guidance document, please contact the
originating office.
Another method of obtaining guidance
documents is through the Division of
Drug Information.
FDA's move to the White Oak Campus means that names, addresses, and phone numbers listed in Agency guidances may no longer be accurate. If you need to speak to someone, contact the office or division that developed a guidance (see footnote 1 in guidances) or contact CDER's Division of
Drug Information.
Newly Added
Guidance Documents Guidance Documents will be
retained in this section of the page for a period of three months. The most
recently added appears first and they are in the order of the date
they were issued.
* Note: Draft guidances are undergoing
finalization. Please contact the relevant division for the most up-to-date
Agency perspective on an issue. For information on how to electronically submit
a comment on a draft guidance, please see
http://www.fda.gov/opacom/backgrounders/voice.html
Guidances Arranged by Subject
Information About Guidances
Newly Added
Guidance Documents:
Guidance Documents will be
retained on this list for a period of three months. After three months you will find them under their specific "subject" on this page. The most
recently added guidances appears first and they are in the order of the date
they were issued.
Title and Format |
Subject |
Type |
Issue Date |
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule [PDF] |
Pharm/Tox |
Draft
note* |
1/16/2009 |
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act [PDF] |
Procedural |
Draft
note* |
1/16/2009 |
Guidance for Clinical Investigators,
Sponsors, and IRBs
Adverse Event Reporting to IRBs —
Improving Human Subject Protection [PDF] or [HTML] |
Procedural |
Final |
1/14/2009 |
| Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices U.S. [HTML] |
Procedural |
Final |
1/14/2009 |
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
- Annex 2
Test for Extractable Volume of Parenteral Preparations General Chapter [PDF] or [HTML]
- Annex 3
Test for Particulate Contamination: Subvisible Particles General Chapter [PDF] or [HTML]
|
International Conference on Harmonisation
-Quality |
Final |
1/8/2009 |
| Labeling OTC Human Drug Products -- Questions and Answers [PDF] or [HTML] |
Over-the-Counter |
Final |
1/2/2009 |
| Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes [PDF] or [HTML] |
Clinical/Medical |
Final |
12/17/2008 |
Orally Disintegrating Tablets [PDF] or [HTML] |
Chemistry |
Final |
12/17/2008 |
| Postmarketing Adverse Even Reporting for Medical products and Dietary Supplements During an Influenza Pandemic [PDF] or [HTML] |
Procedural |
Draft
note* |
12/15/2008 |
| Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches [PDF] or [HTML] |
Pharm/Tox |
Draft
note* |
12/15/2008 |
Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1 [PDF] |
Over-the-Counter |
Draft
note* |
12/8/2008 |
| Cooperative Manufacturing Arrangements for Licensed Biologics [PDF] of [HTML] |
Procedural |
Final |
12/3/2008 |
Sponsors, Clinical Investigators, and IRBs; Data Retention
When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability [PDF] |
Procedural |
Draft
note* |
12/2/2008 |
| Submission of Patent Information for Certain Old Antibiotics [PDF] |
Procedural |
Draft
note* |
11/28/2008 |
Contents of a Complete Submission for the Evaluation of Proprietary Names [PDF] or [HTML] |
Labeling |
Draft
note* |
11/24/2008 |
E14 Clinical Evaluation of QT/QTc Interval Prolongation and
Proarrhythmic Potential for Non-Antiarrhythmic Drugs .
Questions and Answers [PDF] or [HTML] |
International Conference on Harmonisation
-Efficacy |
Final |
11/18/2008 |
Process Validation: General
Principles and Practices [PDF] or [HTML] |
Current Good Manufacturing Practices
(CGMPs)/Compliance |
Draft
note* |
11/17/2008 |
| Tropical Disease Priority Review Vouchers [PDF] or [HTML] |
Procedural |
Draft
note* |
10/21/2008 |
| PDUFA Pilot Project: Proprietary Name Review [PDF] or [HTML] |
Concept Papers |
Final |
10/7/2008 |
| End-of-Phase 2A Meetings [PDF] or [HTML] |
Procedural |
Draft
note* |
9/25/2008 |
| S1C(R2)
Dose Selection for Carcinogenicity Studies of Pharmaceuticals [PDF] or [HTML] |
International Conference on Harmonisation
-Safety |
Final |
9/17/2008 |
| Animal Models — Essential Elements to Address Efficacy Under the Animal Rule [PDF] or [HTML] |
Concept Papers |
Draft
note* |
9/9/2008 |
| M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals [PDF] or [HTML] |
International Conference on Harmonisation
-Joint Safety/Efficacy (Multidisciplinary) |
Draft
note* |
9/3/2008 |
Back to Top
Advertising
|
Title and Format |
Type |
Issue Date |
| Accelerated
Approval Products: Submission of Promotional Materials
[PDF] |
Draft
note* |
3/26/1999 |
| Aerosol Steroid
Product Safety Information in Prescription Drug Advertising and Promotional
Labeling [PDF] |
Final |
12/1997 |
Brief Summary: Disclosing Risk Information in Consumer-Directed Print
Advertisements [HTML] [PDF]
- Labeling Example [PDF]
- Labeling Example; Consumer-Friendly Version [PDF]
|
Draft
note* |
2/4/2004 |
| Consumer-Directed Broadcast Advertisements [HTML] or [PDF]
Questions and
Answers (Posted 8/6/1999) |
Final |
8/1999 |
Consumer-Directed Broadcast Advertising of Restricted
Devices [HTML]
or [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
1/26/2004 |
“Help-Seeking” and Other Disease Awareness
Communications by or on Behalf of Drug and Device Firms [HTML]
or [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
1/26/2004 |
| Industry-Supported Scientific and Educational Activities [HTML] or [PDF] |
Final |
12/3/1997 |
|
Product Name
Placement, Size, and Prominence in Advertising and Promotional Labeling [PDF] |
Draft
note* |
1/1999 |
Back to Top
Biopharmaceutics
|
Title and Format |
Type |
Issue Date |
| Bioanalytical Method Validation [HTML] or [PDF] |
Final |
5/2001 |
Bioavailability and Bioequivalence Studies for Nasal
Aerosols and Nasal Sprays for Local Action [PDF]
Federal Register Notice [ TXT ] [ PDF ]
- Statistical Information from the June 1999
Draft Guidance and Statistical Information for In Vitro Bioequivalence Data [PDF]
| Draft
note* |
4/2/2003
4/11/2003 |
| Bioavailability and Bioequivalence Studies for Orally Administered Drug
Products - General Considerations [HTML]
or [PDF] |
Final |
3/2003 |
| Cholestyramine
Powder in Vitro Bioequivalence [PDF] (Intermin Guidance) |
Final |
7/15/93 |
| Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing [HTML]
or [PDF] |
Final |
6/17/2005 |
| Conjugated Estrogens, USP-LC-MS Method for
Both Qualitative Chemical Characterization and Documentation
of Qualitative Pharmaceutical Equivalence. |
Draft
note*
Withdrawn
FR Notice |
8/12/2005 |
| Corticosteroids,
Dermatologic (topical) In Vivo [PDF] (Issued 6/2/1995, Posted 3/6/1998) |
Final |
6/2/1995 |
| Dissolution Testing
of Immediate Release Solid Oral Dosage Forms [PDF] (Issued 8/1997, Posted 8/25/1997) |
Final |
8/1997 |
| Extended Release
Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In
Vivo Correlations [PDF] |
Final |
9/1997 |
| Food-Effect Bioavailability and Fed Bioequivalence Studies
[HTML] or [PDF] |
Final |
12/2002 |
Metaproterenol
Sulfate and Albuterol Metered Dose Inhalers In Vitro
[PDF] |
Final |
6/27/1989 |
| Potassium Chloride
(slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro
Dissolution Testing [PDF] |
Final |
6/6/1994 |
| Statistical Approaches to Establishing Bioequivalence [HTML] or [PDF] |
Final |
2/2001 |
| Waiver of In Vivo
Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral
Dosage Forms Based on a Biopharmaceutics Classification System.
[HTML] or PDF. |
Final |
8/2000 |
Back to Top
[CGMPs] Current Good Manufacturing
Practice (Pharmaceutical CGMPs for the 21st Century) / Compliance
|
Title and Format |
Type |
Issue Date |
Bar Code Label Requirements--Questions and Answers [PDF]
Federal Register Notice [TXT] [PDF] |
Final |
10/5/2006 |
Comparability Protocols - Protein Drug
Products and Biological Products - Chemistry, Manufacturing,
and Controls Information [PDF]
Federal Register Notice [TXT] [PDF]
|
Draft
note* |
9/3/2003 |
| Compressed Medical
Gases |
Final |
2/1989 |
| Computerized
Systems Used in Clinical Trials [HTML] or [PDF] |
Final |
5/10/2007 |
Current Good Manufacturing Practice for
Combination Products [HTML]
or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
9/29/2004 |
| Current Good Manufacturing Practice for Medical Gases [PDF] Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
5/6/2003 |
| Current Good Manufacturing Practice for Phase 1 Investigational Drugs [PDF] or [HTML] |
Final |
7/14/2008 |
| Expiration Dating
and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron [PDF] |
Final |
6/27/1997 |
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide [HTML]
or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
5/27/2005 |
| Formal Dispute Resolution: Scientific and
Technical Issues Related to Pharmaceutical CGMP [HTML]
or [PDF] |
Final |
1/11/2006 |
| General Principles of
Process Validation |
Final |
5/1987 |
| Good Laboratory
Practice Regulations Questions and Answers [PDF] |
Final |
3/2/1998 |
| Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities -
FDA Public Health Advisory [HTML] or [PDF] |
Final |
4/5/2001 |
Guidance for
IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent
Requirements for Emergency Research (21 CFR 50.24) Draft released for
comment
Federal Register Notice |
Draft
note* |
8/29/2006 |
| Guideline for
Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin
Test for Human and Animal Parenteral Drugs, Biological Products, and Medical
Devices [PDF] |
Final |
Posted 3/2/1998 |
| Investigating Out-of-Specification Test Results for Pharmaceutical Production [PDF] or [HTML] |
Final |
10/11/2006 |
| Manufacturing,
Processing, or Holding Active Pharmaceutical Ingredients[PDF] |
Draft
note* |
4/17/1998 |
| Marketed Unapproved Drugs -- Compliance Policy Guide
[HTML] or [PDF] |
Final |
6/8/2006 |
| Monitoring of
Clinical Investigations [PDF] |
Final |
Posted 3/2/1998 |
| Nuclear Pharmacy
Guideline Criteria for Determining When to Register as a Drug
Establishment [PDF] |
Final |
Posted 3/2/1998 |
| Part 11, Electronic Records; Electronic
Signatures — Scope and Application [HTML]
[PDF] |
Final |
9/3/2003 |
| PAT — A Framework for Innovative
Pharmaceutical Development, Manufacturing, and Quality
Assurance [HTML] [PDF] |
Final |
9/29/2004 |
| PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML]
or [PDF] |
Draft
note* |
9/15/2005 |
| Pharmacy Compounding -- Compliance Policy Guide
[PDF] |
Final |
5/2002 |
| Possible Dioxin/PCB Contamination of Drug and Biological Products [HTML] or [PDF] |
Final |
8/23/1999 |
Powder Blends and Finished Dosage Units —
Stratified In-Process Dosage Unit Sampling and Assessment [HTML]
[PDF]
Federal Register Notice [TXT] [PDF]
- Revised Attachments [PDF]
|
Draft
note* |
11/2003 |
| Preparation of
Investigational New Drug Products (Human and Animal) [PDF] |
Final |
11/1992 |
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to
Free Clinics [HTML] or [PDF]
- Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers [PDF] (Issued and Posted 11/13/2006)
|
Final |
3/2006 |
| Process Validation: General
Principles and Practices [PDF] or [HTML] |
Draft
note* |
11/17/2008 |
Quality Systems Approach to Pharmaceutical
Current Good Manufacturing Practice Regulations [HTML] or
[PDF]
Federal Register Notice [TXT] [PDF] |
Final |
9/27/2006 |
| Questions and Answers on
Current Good Manufacturing Practices (cGMP) for Drugs |
Final |
8/4/2004 |
| Review of FDA's
Implementation of the Drug Export Amendments of 1986 [PDF] |
Final |
11/1989 |
| Sterile Drug Products Produced by Aseptic
Processing — Current Good Manufacturing Practice [HTML]
[PDF] |
Final |
9/29/2004 |
| Street Drug Alternatives [HTML] or [PDF] |
Final |
3/2000 |
| Testing of Glycerin for Diethylene Glycol [ HTML] or [PDF] |
Final |
5/1/2007 |
| The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Good Manufacturing Practice (CGMP) [PDF] or [HTML] |
Draft
note* |
10/18/2007 |
Back to Top
Chemistry
|
Title and Format |
Type |
Issue Date |
Analytical Procedures
and Methods Validation. Optional format:
PDF.
Federal Register Notice [TXT] [PDF] |
Draft
note* |
8/2000 |
| BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives
Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
2/2001 |
Final |
Withdrawn as per FR notice June
1, 2006 |
| Botanical Drug Products [HTML] or
[PDF] |
Final |
6/2004 |
| Changes to an
Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
[PDF] |
Final |
7/1997 |
| Changes to an Approved NDA or ANDA
[HTML] or
[PDF] |
Final |
4/2004 |
| Changes to an Approved NDA or ANDA: Questions and Answers
[HTML] or
[PDF] |
Final |
1/2001 |
| Changes to an Approved NDA or ANDA; Specifications – Use of
Enforcement Discretion for Compendial Changes [HTML] or
[PDF] |
Final |
11/19/2004 |
Comparability Protocols -- Chemistry, Manufacturing, and
Controls Information
[PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
2/2003 |
Container Closure Systems for Packaging Human Drugs and Biologics
[HTML] or
[PDF]
- Container Closure Systems for Packaging Human Drugs and Biologics --
Questions and Answers [PDF]
|
Final |
5/1999
5/2002 |
| Demonstration of
Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products |
Final |
4/1996 |
| Development of New
Stereoisomeric Drugs |
Final |
5/1/1992 |
Drug Master Files
Current DMF Information
(e.g. lists, addresses, guidances, etc.) |
Final |
9/1/1989 |
| Drug Master Files for Bulk Antibiotic Drug Substances
[HTML] or [PDF] |
Final |
11/1999 |
| Drug Product: Chemistry,
Manufacturing, and Controls Information 1/2003 |
Draft
note* |
Withdrawn as per FR notice June
1, 2006 |
| Drug Substance: Chemistry,
Manufacturing, and Controls Information 1/2004 |
Draft
note* |
Withdrawn as per FR notice June
1, 2006 |
| Drugs, Biologics, and
Medical Devices Derived from Bioengineered Plants for Use in Humans and
Animals [PDF] |
Draft
note* |
9/11/2003 |
| Environmental
Assessment of Human Drug and Biologics Applications [PDF] |
Final |
7/1998 |
| Format and Content
of the Chemistry, Manufacturing and Controls Section of an Application* 2/1987 |
Final |
Withdrawn as per FR notice June
1, 2006 |
| Format
and Content for the CMC Section of an Annual Report [PDF] |
Final |
9/1/1994 |
| INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and
Controls Information [HTML] or [PDF] |
Final |
5/20/2003 |
| IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and
Controls Information [HTML] or [PDF] |
Final |
5/2001 |
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug
Regulations [HTML] or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
7/24/1999 |
Liposome Drug Products: Chemistry, Manufacturing,
and Controls; Human Pharmacokinetics and Bioavailability; and Labeling
Documentation. [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
7/2002 |
| Monoclonal Antibodies Used as Reagents in Drug Manufacturing [HTML] or [PDF] |
Final |
3/2001 |
| Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products [HTML] or [PDF] |
Draft
note* |
11/13/1998 |
| Nasal Spray and Inhalation Solution, Suspension, and Drug Products [HTML]
or [PDF] |
Final |
7/2002 |
| NDAs: Impurities in Drug Substances [HTML] or [PDF] |
Final |
2/2000 |
| Orally Disintegrating Tablets [PDF] or [HTML] |
Final |
12/17/2008 |
| PAC-ATLS:
Postapproval Changes - Analytical Testing Laboratory Sites [PDF] |
Final |
4/28/1998 |
| Residual Solvents in Drug Products Marketed in the United States [PDF] or [HTML] |
Draft
note* |
8/6/2008 |
Reviewer Guidance,
Validation of Chromatographic Methods [PDF]
(revised to include graphics, 5/14/2007) |
Final |
11/1994 |
| The
Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by
Bovine Spongiform Encephalopathy (BSE) |
Final |
12/20/2000 |
| Stability Testing
of Drug Substances and Drug Products 6/5/1998 |
Draft
note* |
Withdrawn as per FR notice June
1, 2006 |
| Submission of
Chemistry, Manufacturing, and Controls Information for Synthetic Peptide
Substances 11/1994 |
Final |
Withdrawn as per FR notice June
1, 2006 |
| Submitting Documentation for the Manufacturing of and Controls for Drug
Products* [HTML]
or [PDF] |
Final |
2/1987 |
| Submitting
Documentation for the Stability of Human Drugs and Biologics* (Issued
, Posted 3/2/1998) |
Final |
Withdrawn as per FR notice June
1, 2006 |
| Submitting Samples
and Analytical Data for Methods Validation |
Final |
2/1987 |
| Submitting
Supporting Documentation in Drug Applications for the Manufacture of Drug
Substances [PDF] |
Final |
2/1987 |
| SUPAC-IR:
Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes:
Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In
Vivo Bioequivalence Documentation [PDF] |
Final |
11/1995 |
| SUPAC-IR Questions
and Answers about SUPAC-IR Guidance |
Final |
2/18/1997 |
| SUPAC-IR/MR:
Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing
Equipment Addendum [PDF] |
Final |
1/1999 |
| SUPAC-MR: Modified
Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry,
Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo
Bioequivalence Documentation [PDF] |
Final |
Issued 10/6/1997 |
| SUPAC-SS:
Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum [PDF] |
Draft
note* |
12/1998 |
| SUPAC-SS:
Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes:
Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo
Bioequivalence Documentation [PDF] |
Final |
5/1997 |
Back to Top
Clinical Antimicrobial
|
Title and Format |
Type |
Issue Date |
| Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment [PDF] or [HTML] |
Draft
note* |
8/21/2008 |
| Acute Bacterial
Meningitis — Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Acute Bacterial
Sinusitis — Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
10/29/2007 |
| Acute or Chronic
Bacterial Prostatitis — Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Acute Bacterial Otitis Media: Developing Drugs for Treatment [PDF] or [HTML] |
Draft
note* |
1/17/2008 |
| Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval [PDF] or [HTML] |
Draft
note* |
10/12/2007 |
Antiviral Product Development--Conducting and
Submitting Virology Studies to the Agency [PDF]
or [HTML]
- Guidance for Submitting HIV Resistance Data [HTML]
or [PDF]
- Guidance for Submitting Influenza Resistance Data [HTML]
or [PDF]
- Guidance for Submitting HBV Resistance Data [HTML]
or [PDF]
- Guidance for Submitting HCV Resistance Data [HTML]
or [PDF]
|
Final |
6/2/2006 |
| Antiretroviral Drugs Using Plasma HIV RNA Measurements — Clinical
Considerations for Accelerated and Traditional Approval [HTML]
or [PDF] |
Final |
10/2002 |
|
Bacterial Vaginosis
— Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs
for Treatment [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
10/1999 |
| Clinical Development and Labeling of Anti-Infective Drug Products [HTML] or [PDF] |
Final |
10/1992 Revised 2/12/2001 |
| Clinical
Evaluation of Anti-Infective Drugs (Systemic) [PDF] |
Final |
9/77 |
| Community-Acquired
Pneumonia — Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Complicated Urinary Tract Infections and Pyelonephritis
— Developing Antimicrobial Drugs for Treatment [HTML] or [PDF] |
Draft
note* |
7/22/1998 |
| Developing
Antimicrobial Drugs — General Considerations for Clinical Trials [PDF] [Main Document] |
Draft
note* |
7/22/1998 |
Developing Antimicrobial Drugs to Treat Inhalational Anthrax (Post Exposure) --
[HTML]
or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
3/15/2002 |
| Empiric Therapy of
Febrile Neutropenia — Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Evaluating
Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug
Products [PDF] |
Draft
note* |
2/18/1997 |
| Lyme Disease —
Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Nosocomial
Pneumonia — Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
[PDF] or [HTML]
|
Final
|
10/30/2007 |
| Secondary Bacterial
Infections of Acute Bronchitis — Developing Antimicrobial Drugs for
Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention [PDF] or [HTML] |
Draft
note* |
11/21/2007 |
| Streptococcal
Pharyngitis and Tonsillitis — Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Uncomplicated and
Complicated Skin and Skin Structure Infections — Developing Antimicrobial
Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Uncomplicated
Gonorrhea — Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998, |
| Uncomplicated
Urinary Tract Infections — Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices [PDF] or [HTML] |
Draft
note* |
6/11/2008 |
Vaccinia Virus — Developing Drugs to Mitigate Complications
from Smallpox Vaccination [HTML] or
[PDF]
Federal Register Notice [TXT] [PDF]
|
Draft
note* |
3/8/2004 |
| Vulvovaginal
Candidiasis — Developing Antimicrobial Drugs for Treatment
[PDF] |
Draft
note* |
7/22/1998 |
Back to Top
Clinical/Medical
|
Title and Format |
Type |
Issue Date |
| Acceptance of Foreign Clinical Studies
[HTML] or
[PDF] |
Final |
3/12/2001 |
Acne Vulgaris: Developing Drugs for Treatment [HTML]
or [PDF]
Federal Register Notice [TXT] [ PDF] |
Draft
note* |
9/16/2005 |
| Allergic Rhinitis: Clinical Development Programs for Drug Products [HTML] or [PDF] |
Draft
note* |
6/2000 |
| Antianxiety Drugs--Clinical
Evaluation [PDF] |
Final |
9/1977 |
| Antidepressant Drugs--Clinical Evaluation [PDF] |
Final |
9/1977 |
| Available Therapy [HTML] or [PDF] |
Final |
7/22/2004 |
| Calcium DTPA and Zinc DTPA Drug Products - Submitting a
New Drug Application [HTML] or [PDF] |
Final |
8/13/2004 |
| Cancer Drug and Biological Products - Clinical Data in Marketing
Applications [HTML]
or [PDF] |
Final |
10/11/2001 |
| Chronic Cutaneous Ulcer and Burn
Wounds -- Developing Products for Treatment [PDF]
or [HTML] |
Final |
6/1/2006 |
| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment [PDF] or [HTML] |
Draft
note* |
11/8/2007 |
Clinical Development Programs for Drugs, Devices, and Biological Products
Intended for the Treatment of Osteoarthritis [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
7/07/1999 |
| Clinical Development Programs for
Drugs, Devices, and Biological Products for the Treatment of
Rheumatoid Arthritis (RA) [HTML]
or [PDF] |
Final |
1/1999 |
| Clinical Evaluation of Analgesic
Drugs (Withdrawn per August 5, 2003, Federal
Register Notice) |
Final
|
Withdrawn
8/5/2003 |
| Clinical
Evaluation of Antacid Drugs (Withdrawn per July 20, 2004, Federal
Register notice.) |
Final |
Withdrawn
7/20/2004 |
| Clinical
Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and
children) |
Final |
Withdrawn
5/29/2008 |
| Clinical
Evaluation of Antidiarrheal Drugs (Withdrawn per July 20, 2004, Federal
Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Clinical
Evaluation of Antiepileptic Drugs (adults and children) [PDF] |
Final |
1/1981 |
| Clinical
Evaluation of Gastric Secretory Depressant (GSD) Drugs (Withdrawn per
July 20, 2004, Federal Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Clinical
Evaluation of General Anesthetics [PDF] |
Final |
5/1982 |
| Clinical
Evaluation of Laxative Drugs (Withdrawn per July 20, 2004, Federal
Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Clinical Evaluation of Lipid-Altering Agents [PDF] |
Draft
note* |
10/1990 |
| Clinical
Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal
Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
Clinical Trial Endpoints for the Approval of Cancer
Drugs and Biologics [HTML] or [PDF]
|
Final |
5/15/2007 |
| Collection of Race and Ethnicity Data in Clinical Trials [HTML]
or [PDF] |
Final |
9/16/2005 |
| Content and Format of
Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
Including Well-Characterized, Therapeutic, Biotechnology-derived Products [PDF] |
Final |
11/1995 |
Developing Medical Imaging Drug and Biological Products
- Part 1: Conducting Safety Assessments [HTML]
or [PDF]
- Part 2: Clinical Indications [HTML] or [PDF]
- Part 3: Design, Analysis, and Interpretation of Clinical Studies [HTML]
or [PDF]
|
Final |
6/17/2004 |
| Developing Products for Weight Management Revision 1 [PDF] or [HTML] |
Draft
note* |
2/14/2007 |
| Development and Use of Risk Minimization Action Plans [HTML]
or [PDF] |
Final |
3/24/2005 |
Development of Parathyroid Hormone for the Prevention and Treatment of
Osteoporosis [HTML]
or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
5/2000 |
| Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention [PDF] or [HTML] |
Draft
note* |
2/29/2008 |
| Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes [PDF] or [HTML] |
Final |
12/17/2008 |
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants
for Use in Humans and Animals [HTML] or
[PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
9/6/2002 |
| Establishing Pregnancy Exposure Registries [HTML]
or [PDF] |
Final |
8/2002 |
| Establishment and Operation of Clinical Trial Data Monitoring
Committees [PDF] |
Final |
3/27/2006 |
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms
and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical
Evaluation or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
1/2003 |
| Evaluating the Risks of Drug Exposure in Human
Pregnancies [HTML] or [PDF]
|
Final |
4/27/2005 |
Exercise-Induced Bronchospasm (EIB) — Development of Drugs to Prevent
EIB [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
2/2002 |
|
Exocrine Pancreatic Insufficiency Drug Products--Submitting
New Drug Applications [HTML] or [PDF] |
Final |
4/13/2006 |
Female Sexual Dysfunction: Clinical Development of Drug Products for
Treatment [HTML] or
[PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
5/2000 |
| FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological
Products [HTML] or
[PDF] |
Final |
12/1998 |
| FDA Requirements
for Approval of Drugs to Treat Non-Small Cell Lung Cancer [PDF] |
Final |
Posted 3/2/1998 |
| FDA Requirements
for Approval of Drugs to Treat Superficial Bladder Cancer (Withdrawn per July
20, 2004, Federal Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Format and Content
of the Clinical and Statistical Sections of an Application [PDF] |
Final |
7/1988 |
| Formatting,
Assembling and Submitting New Drug and Antibiotic Applications* [PDF] |
Final |
2/1987 |
| General
Considerations for the Clinical Evaluation of Drugs [PDF] |
Final |
|
| General
Considerations for the Clinical Evaluation of Drugs in Infants and
Children [PDF] |
Final |
9/77 |
Gingivitis: Development and Evaluation of Drugs for Treatment or
Prevention [HTML] or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
6/24/ 2005 |
| Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment [HTML] or [PDF]
|
Final |
3/24/2005 |
| Guidance for Clinical Trial Sponsors On the
Establishment and Operation of Clinical Trial Data Monitoring
Committees [PDF] |
Final |
3/27/2006 |
Guidance for
Institutional Review Boards, Clinical Investigators, and Sponsors: Exception
from Informed Consent Requirements for Emergency Research
Federal Register Notice |
Draft
note* |
8/29/2006 |
|
Guidance for the
Development of Vaginal Contraceptive Drugs (NDA)[PDF] |
Final |
3/2/1998 |
|
Hypnotic Drugs--Clinical Evaluation [PDF] |
Final |
9/77 |
| IND Exemptions for Studies of Lawfully Marketed Drug or Biological
Products for the Treatment of Cancer [HTML] or [PDF] |
Final |
Revised 1/15/2004 |
Inhalation Drug Products Packaged in Semipermeable Container Closure
Systems [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
7/2002 |
| Integration of Dose-Counting Mechanisms into MDI Drug Products
[HTML] or [PDF] |
Final |
3/2003 |
| Internal Radioactive Contamination —Development of Decorporation
Agents [HTML] or [PDF] |
Final |
3/1/2006 |
| Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability
Studies and In Vitro Dissolution Testing [HTML] or [PDF] |
Final |
2/2001 |
| Local
Anesthetics--Clinical Evaluation [PDF] |
Final |
3/2/1998 |
| Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis [PDF] |
Draft
note* |
6/6/2007 |
| MDI
and DPI Drug Products--Clinical Development Programs for
[PDF] |
Final |
9/19/1994 |
|
Pediatric Use Supplements--Content
and Format [PDF] |
Final |
5/1996 |
| Oncologic Drugs
Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for
Treatment of Colon and Rectal Cancer [PDF] |
Final |
Posted 3/2/1998 |
| Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children [PDF] or [HTML] |
Final |
3/5/2007 |
OTC Treatment of Herpes Labialis with Antiviral Agents [HTML] or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
3/8/2000 |
Patient-Reported Outcome
Measures: Use in Medical Product Development to Support Labeling Claims [HTML]
or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
2/2/2006 |
Pediatric Oncology Studies In Response to a Written Request
[HTML] or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
6/2000 |
| Postmarketing
Adverse Experience Reporting for Human Drug and Licensed Biological Products:
Clarification of What to Report [PDF] |
Final |
8/27/1997 |
Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application [PDF] or [HTML]
|
Draft
note* |
10/11/2007 |
| Postmarketing
Reporting of Adverse Drug Experiences [PDF] |
Final |
3/1992 |
| Preclinical and
Clinical Evaluation of Agents Used in the Prevention or Treatment of
Postmenopausal Osteoporosis [PDF] |
Draft
note* |
4/1994 |
|
Premarketing Risk Assessment [HTML]
or [PDF] |
Final |
3/24/2005 |
| Providing Clinical
Evidence of Effectiveness for Human Drug and Biological Products [PDF] |
Final |
5/14/1998 |
| Prussian Blue Drug Products — Submitting a New Drug Application
[HTML] or
[PDF] |
Final |
1/2003 |
| Psychoactive Drugs in Infants and Children--Clinical
Evaluation [PDF] |
Final |
3/2/1998 |
| Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a)
and 601.27(a)) [HTML] or [PDF] |
Draft
note* |
Posted 12/1/2000 |
| Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment [PDF] or [HTML] |
Draft
note* |
Posted 11/21/2006 |
| Study and
Evaluation of Gender Differences in the Clinical Evaluation of Drugs [PDF] |
Final |
7/22/1993 |
| Study of Drugs
Likely to be used in the Elderly [PDF] |
Final |
11/1989 |
| Submission of Abbreviated Reports and Synopses in Support of Marketing
Applications [HTML]
or [PDF] |
Final |
8/1999 |
| Summary for New Drug and Antibiotic Applications--Format and
Content of the * [PDF] |
Final |
2/1987 |
| Systemic Lupus Erythematosus --Developing Drugs for
Treatment [HTML]
or [PDF] |
Draft
note* |
3/28/2005 |
| The Use of Clinical Holds Following Clinical Investigator Misconduct [HTML] or [PDF] |
Final |
9/2004 |
| Waiver of IRB Requirements for Drug and Biological Product Studies [PDF] |
Final |
1/2006 |
Back to Top
Clinical Pharmacology
|
Title and Format |
Type |
Issue Date |
Clinical Lactation Studies--Study Design, Data Analysis, and
Recommendations for Labeling [HTML] or
[PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
Issued 2/7/05 |
Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling [PDF] or [HTML]
Federal Register Notice: [TXT] [PDF] |
Draft
note* |
Issued 9/11/2006 |
| Drug Metabolism/Drug
Interaction Studies in the Drug Development Process: Studies In Vitro [PDF]
(Issued, Posted 4/8/1997) |
Final |
4/1997 |
| Exposure-Response Relationships — Study Design, Data Analysis, and
Regulatory Applications [HTML] or
[PDF] |
Final |
5/5/2003 |
| Format and Content
of the Human Pharmacokinetics and Bioavailability Section of an Application* [PDF] |
Final |
2/1987 |
| General
Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products [PDF] |
Draft
note* |
11/1998 |
| In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data
Analysis, and Recommendations for Dosing and Labeling [HTML] or
[PDF] |
Final |
11/24/1999 |
| Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design,
Data Analysis, and Impact on Dosing and Labeling [HTML]
or [PDF] |
Final |
Posted 5/30/2003 |
| Pharmacokinetics in Patients with
Impaired Renal Function [PDF] |
Final |
5/14/1998 |
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on
Dosing and Labeling [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
10/29/2004 |
| Population Pharmacokinetics [PDF]
(Issued , Posted 2/10/1999) |
Final |
2/1999 |
CMC Microbiology (Chemistry, Manufacturing, and Controls)
| Title and Format |
Type |
Issue Date |
| Submission
Documentation for Sterilization Process Validation in Applications for Human
and Veterinary Drug Products [PDF] |
Final |
11/1994 |
| Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes [PDF] or [HTML] |
Draft
note* |
8/4/2008 |
Combination Products (Drug/Device/Biologic)
| Title and Format |
Type |
Issue Date |
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies [PDF] or [HTML]
|
|
3/26/2008 |
Concept Papers
| Title and Format |
Type |
Issue Date |
Animal Models — Essential Elements to Address Efficacy Under the Animal Rule [PDF] or [HTML] |
|
9/9/2008 |
| PDUFA Pilot Project: Proprietary Name Review [PDF] or [HTML] |
Final |
10/7/2008 |
Back to Top
Drug Safety
|
Title and Format |
Type |
Issue Date |
| Conducting a Clinical Safety Review of a New Product Application
and Preparing a Report on the Review [HTML]
or [PDF] |
Final |
2/2005 |
| Drug-Induced Liver Injury:
Premarketing Clinical Evaluation [PDF] or [HTML] |
|
10/24/2007 |
Drug Safety Information - FDA's Communication to the Public [PDF] or [HTML]
Federal Register Notice [TXT] [PDF] |
Final |
3/2/2007 |
Electronic Submissions
|
Title and Format |
Type |
Issue Date |
| Indexing Structured Product Labeling [PDF] or [HTML] |
Final |
6/2/2008 |
| Part 11, Electronic Records; Electronic Signatures — Scope and Application
[HTML] [PDF] |
Final |
9/3/2003 |
Providing Regulatory Submissions in Electronic Format — ANDAs
Withdrawn
FR Notice 10/5/2006 |
Final
Withdrawn
FR Notice
|
6/2002 |
Providing Regulatory Submissions in Electronic Format -
Annual Reports for
NDAs and ANDAs
Withdrawn
FR Notice 10/5/2006 |
Draft
note*
Withdrawn
FR Notice |
Posted 8/27/2003 |
| Providing Regulatory Submissions in Electronic Format — Content of
Labeling [HTML] or [PDF]
|
Final |
4/20/2005 |
Providing Regulatory Submissions in Electronic Format –
Drug Establishment Registration and Drug Listing [PDF] or [HTML] |
Draft
note* |
7/10/2008 |
Providing Regulatory Submissions in Electronic Format -
Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications [PDF]
To ensure that you have the most recent versions of the specifications referenced in this document, check the appropriate center's Web page.
For CBER, this Web page is http://www.fda.gov/cber/esub/esub.htm
For CDER, this Web page is http://www.fda.gov/cder/regulatory/ersr/ectd.htm |
Final |
revised
06/11/2008 |
Providing Regulatory Submissions in Electronic Format -
General
Considerations or [PDF]
(Issued , Posted 10/22/2003)
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
10/2003 |
Providing Regulatory Submissions in Electronic Format –
Postmarketing Individual Case Safety Reports [PDF]or [HTML]
To ensure that you have the most recent versions of the
specifications referenced in this document, check the appropriate
center's Web page.
For CBER, the Web page is
http://www.fda.gov/cber/esub/icsr.htm.
For CDER, the Web page is
http://www.fda.gov/cder/regulatory/ersr/#Postmarketing.
|
Draft
note* |
6/11/2008 |
Providing Regulatory Submissions in Electronic Format - Prescription Drug
Advertising and Promotional Labeling [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
1/2001 |
| Providing Regulatory Submissions in Electronic Format--Receipt Date [HTML] or [PDF] |
Draft
note* |
6/4/2007 |
|
Regulatory
Submissions in Electronic Format; General Considerations [PDF] |
Final |
1/1999 |
Regulatory
Submissions in Electronic Format; New Drug Applications
Withdrawn
FR Notice 10/5/2006 |
Final
Withdrawn
FR Notice |
1/1999 |
| SPL Standard for Content of Labeling Technical Qs & As [HTML]
or [PDF] |
Final |
12/2005 |
FDAAA (Food and Drug Administration Amendments Act)
| Title and Format |
Type |
Issue Date |
Certifications To Accompany Drug, Biological Product, and Device
Applications/Submissions:Compliance with Section 4020) of
The Public Health Service Act,
Added By Title VIII of The Food and Drug Administration
Amendments Act of 2007
[PDF] |
Draft
note* |
4/2008 |
Back to Top
Generics
|
Title and Format |
Type |
Issue Date |
|
180-Day Exclusivity When Multiple ANDAs Are Submitted on the
Same Day [HTML] or [PDF] |
Final |
7/2003 |
| Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs
[HTML] or [PDF] |
Final |
12/2000 |
ANDAs: Impurities
in Drug Products [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
8/26/2005 |
| ANDA's: Impurities in Drug Substances [HTML] or [PDF] |
Final |
11/1999 |
ANDAs: Impurities in Drug Substances [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
1/28/2005 |
| ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information [PDF] |
Final |
7/6/2007 |
| Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the
Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF] |
Final |
3/2000 |
| Handling and Retention of Bioavailability and Bioequivalence Testing Samples
[HTML]
or [PDF] |
Final |
5/25/2004 |
Individual Product Bioequivalence Recommendations [PDF]
List of Product Bioequivalence Recommendations |
Draft
note* |
5/30/2007 |
|
Letter announcing
that the OGD will now accept the ICH long-term storage conditions as well as
the stability studies conducted in the past. [PDF] |
Final |
8/1995 |
| Letter describing
efforts by the CDER and the ORA to clarify the responsibilities of CDER
chemistry review scientists and ORA field investigators in the new and
abbreviated drug approval process in order to reduce duplication or redundancy
in the process [PDF] |
Final |
10/1994 |
| Letter on
incomplete Abbreviated Applications, Convictions Under GDEA, Multiple
Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal
Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy [PDF] |
Final |
4/1994 |
| Letter on the
Provision of new information pertaining to new bioequivalence guidelines and
refuse-to-file letters [PDF] |
Final |
7/1992 |
| Letter on the
provision of new procedures and policies affecting the generic drug review
process [PDF] |
Final |
3/1989 |
| Letter on the
request for cooperation of regulated industry to improve the efficiency and
effectiveness of the generic drug review process, by assuring the completeness
and accuracy of required information and data submissions [PDF] |
Final |
11/1990 |
| Letter on the
response to 12/20/1984 letter from the Pharmaceutical Manufacturers
Association about the Drug Price Competition and Patent Term Restoration
Act [PDF] |
Final |
3/1985 |
| Letter to all ANDA
and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and
the Office of Generic Drugs intention to refuse-to-file incomplete submissions
as required by the new law [PDF] |
Final |
1/1993 |
| Letter to
regulated industry notifying interested parties about important detailed
information regarding labeling, scale-up, packaging, minor/major amendment
criteria and bioequivalence requirements [PDF] |
Final |
8/1993 |
Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications
Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 -- Questions and Answers [HTML]
or [PDF].
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
10/2004 |
| Major, Minor, and Telephone Amendments to Abbreviated New Drug
Applications [HTML] or [PDF] |
Final |
12/2001 |
| Potassium Chloride Modified-Release Tablets and Capsules: In Vivo
Bioequivalence and In Vitro Dissolution Testing [HTML]
or [PDF] |
Final |
10/25/2005 |
| Revising ANDA Labeling Following Revision of the RLD Labeling [HTML] or [PDF] |
Final |
4/26/2000 |
| Variations in Drug
Products that May Be Included in a Single ANDA [PDF] |
Final |
12/1998 |
Back to Top
Good Review Practices
|
Title and Format |
Type |
Issue Date |
| Conducting a Clinical Safety Review of a New Product Application
and Preparing a Report on the Review [HTML] or
[PDF] |
Final |
2/2005 |
| Pharmacology/Toxicology Review Format
[PDF] |
Final |
5/2001 |
International Conference on Harmonisation -
Efficacy
|
Title and Format |
Type |
Issue Date |
| E1A The Extent of Population
Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of
Non-Life-Threatening Conditions [PDF] |
Final |
3/1995 |
| E2A Clinical Safety
Data Management: Definitions and Standards for Expedited Reporting [PDF] |
Final |
3/1995 |
E2B International
Conference on Harmonisation; Guidance on Data Elements for Transmission of
Individual Case Safety Reports
[PDF]
- E2BM Data Elements for Transmission Of Individual
Case Safety Reports
(Issued 4/2002, Posted 4/4/2002) [PDF]
- E2B(M) Questions and Answers [HTML]
or [PDF]
(Revised 3/09/2005,
Posted,
3/16/2005)
|
Final |
1/15/1998 |
E2B(R) Clinical Safety Data Management: Data Elements for
Transmission of Individual Case Safety Reports [HTML]
or [PDF]
(Issued , Posted 9/30/2005)
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
9/30/2005 |
E2C(R1) Clinical Safety
Data Management: Periodic Safety Update Reports for Marketed Drugs
Note: In November 2005, the ICH incorporated the E2C addendum with the E2C parent guidance and retitled the combined document E2C(R1). The contents of the two guidances were not revised.
- E2C Clinical Safety
Data Management: Periodic Safety Update Reports for Marketed Drugs [PDF]
- E2C Addendum to ICH E2C Clinical Safety Data Management: Periodic Safety
Update Reports for Marketed Drugs [HTML] or [PDF]
|
Final
Final
|
5/19/1997
2/5/2004
|
E2D Postapproval Safety Data Management: Definitions and Standards for
Expedited Reporting [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
9/12/2003 |
| E2E Pharmacovigilance Planning [HTML]
or [PDF] |
Final |
3/31/05 |
E2F Development Safety Update Report [PDF] or [HTML] |
Draft
note* |
8/4/2008 |
| E3 Structure and
Content of Clinical Study Reports [PDF] |
Final |
7/1996 |
| E4 Dose-Response
Information to Support Drug Registration [PDF] |
Final |
7/1996 |
E5 Ethnic Factors in the Acceptability of Foreign
Clinical Data [PDF]
- E5 Questions and Answers
[HTML] or [PDF] [Issued 9/27/2006; Posted 9/28/2006]
|
Final |
6/2004 |
E6 Good Clinical
Practice: Consolidated Guideline [PDF]
Spanish Version [PDF] |
Final |
5/9/1997 |
| E7 Studies in Support
of Special Populations: Geriatrics [PDF] |
Final |
8/1994 |
| E8 General
Considerations for Clinical Trials [PDF] |
Final |
12/1997 |
| E9 Statistical Principles for Clinical Trials [PDF] |
Final |
9/1/1998 |
| E10 Choice of Control Group and Related Issues in Clinical Trials [HTML] or [PDF] |
Final |
5/2001 |
| E11 Clinical Investigation of Medicinal Products in the Pediatric
Population [PDF] |
Final |
12/2000 |
E12A Principles for
Clinical Evaluation of New Antihypertensive Drugs. Optional Format:
[PDF].
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
8/2000 |
E14 Clinical Evaluation of QT/QTc Interval Prolongation and
Proarrhythmic Potential for Non-Antiarrhythmic Drugs [HTML]
or [PDF]
Questions and Answers [PDF] or [HTML]
|
Final |
10/19/2005
11/18/2008
|
| E15 Pharmacogenomics Definitions and Sample Coding [HTML] or [PDF] |
Final
|
4/7/2008 |
Back to Top
International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)
|
Title and Format |
Type |
Issue Date |
M2 eCTD: Electronic Common Technical Document Specification
[PDF]
- M2: eCTD Specification Questions and Answers and Change Requests
[HTML]
or [PDF]
|
Final |
4/1/2003
3/14/05
7/10/2008 |
| M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals [PDF] or [HTML] |
Draft
note* |
9/3/2008 |
| M3 Nonclinical Safety Studies for the
Conduct of Human Clinical Trials for Pharmaceuticals
[PDF] |
Final |
11/1997 |
M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use
- M4: Organization of the CTD [HTML] or
[PDF]
- M4 Granularity Annex [HTML]
or
[PDF] (Issued 10/18/2005, Posted 10/18/2005)
- M4: The CTD -- General Questions and Answers [HTML]
or [PDF] (Issued 12/04, Posted 12/22/2004)
- M4: The CTD -- Quality [HTML] or
[PDF]
- M4: The CTD -- Quality Questions and Answers /Location Issues
[HTML]
or [PDF] (Issued 6/2004, Posted 6/8/2004)
- M4: The CTD -- Efficacy [HTML] or
[PDF]
- M4: The CTD -- Efficacy Questions and Answers [HTML]
or [PDF] (Issued 12/2004, Posted 12/22/2004)
Clarification for Q&A 10 on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format [esrs/eCTD page].
- M4: The CTD -- Safety [HTML] or
[PDF]
- M4: The CTD -- Safety Appendices [HTML] or
[PDF]
- M4: The CTD -- Safety Questions and Answers [HTML]
or [PDF] (Issued 2/2003, Posted 2/4/2003)
|
Final |
Originally Issued 10/15/2001 |
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements
and Standards for Drug Dictionaries [HTML]
or
[PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
9/2005 |
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations
[PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
9/2001 |
Back to Top
International Conference on Harmonisation-Quality
|
Title and Format |
Type |
Issue Date |
| Q1A(R2) Stability Testing of New Drug Substances and Products
[HTML] or [PDF] |
Final |
11/2003 |
| Q1B Photostability Testing of New Drug Substances and Products [HTML] or [PDF] |
Final |
11/1996, |
| Q1C Stability
Testing for New Dosage Forms [PDF] |
Final |
5/9/1997 |
| Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug
Substances and Products [HTML] or [PDF] |
Final |
1/2003 |
| Q1E Evaluation of Stability Data [HTML] or [PDF] |
Final |
6/2004 |
| Q1F Stability Data Package for Registration
Applications in Climatic Zones III and IV, revision 1 |
Final |
Withdrawn 7/6/2006 |
Q2(R1) Validation of Analytical Procedures: Text and Methodology
Note: In November 2005, the ICH incorporated Q2B on methodology with the parent guidance Q2A and retitled the combined Q2 document. The contents of the two guidances were not revised.
- Q2A Text on
Validation of Analytical Procedures [PDF]
- Q2B Validation of
Analytical Procedures: Methodology [PDF]
|
Final
Final
|
3/1995
5/19/1997
|
| Q3A(R) Impurities in New Drug Substances [PDF] or [HTML] |
Final |
6/6/2008 |
| Q3B(R) Impurities in New Drug Products (Revision 2) (HTML) or [PDF] |
Final |
8/4/2006 |
| Q3C Impurities: Residual Solvents
[HTML]or [PDF] |
Final |
12/24/1997 |
| Q3C Tables and List [HTML]
or [PDF] |
Final |
11/12/2003 |
|
Final |
2/11/2002
|
| Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions [PDF] or [HTML] |
Final |
2/20/2007 |
- Annex I: Residue on Ignition/Sulphated Ash General Chapter [PDF][ or [HTML]
|
Final |
2/20/2007 |
- Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter [PDF] or [HTML]
|
Final |
1/8/2009 |
- Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter [PDF] or [HTML]
|
Final |
1/8/2009 |
- Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter [PDF] or [HTML]
- Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter [PDF] or [HTML]
- Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter [PDF] or [HTML]
- Annex 5: Disintegration Test General Chapter [PDF] or [HTML]
|
Draft
note* |
8/4/2008 |
| Q5A Viral Safety Evaluation of Biotechnology
Products Derived From Cell Lines of Human or Animal Origin [PDF] |
Final |
Posted 9/1998 |
| Q5B Quality of
Biotechnological Products: Analysis of the Expression Construct in Cells Used
for Production of r-DNA Derived Protein Products [PDF] |
Final |
2/1996 |
| Q5C Quality of
Biotechnological Products: Stability Testing of Biotechnological/Biological
Products [PDF] |
Final |
7/1996 |
| Q5D Quality of
Biotechnological/Biological Products: Derivation and Characterization of Cell
Substrates Used for Production of Biotechnological/Biological Products;
Availability [PDF] (Issued , Posted 9/21/1998) |
Final |
9/21/1998 |
| Q5E Comparability of Biotechnological/Biological Products Subject to
Changes in Their Manufacturing Process [HTML] or [PDF] |
Final |
6/2005 |
| Q6A International Conference on Harmonisation; Guidance on Q6A
Specifications: Test Procedures and Acceptance Criteria for New Drug
Substances and New Drug Products: Chemical Substances. [HTML] or [PDF] |
Final |
12/29/2000 |
| Q6B Specifications: Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products [PDF] |
Final |
8/1999 |
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical
Ingredients [HTML]
or [PDF]
Note: In November 2005, the ICH redesignated this guidance Q7. The guidance was not revised. |
Final
|
8/2001
|
| Q8 Pharmaceutical Development [HTML] or [PDF] |
Final |
5/19/2006 |
| Q8(R1) Pharmaceutical Development Revision 1 [PDF] or [HTML] |
Draft
note* |
1/10/2008 |
| Q9 Quality Risk Management [PDF]
or [HTML] |
Final |
6/1/2006 |
| Q10 Pharmaceutical Quality System[PDF] or [HTML] |
Draft
note* |
7/12/2007 |
Back to Top
International Conference on Harmonisation -
Safety
|
Title and Format |
Type |
Issue Date |
| S1A The Need for
Long-term Rodent Carcinogenicity Studies of Pharmaceuticals [PDF] |
Final |
3/1996 |
| S1B Testing for
Carcinogenicity of Pharmaceuticals [PDF] |
Final |
2/28/1998 |
| S1C(R2)
Dose Selection for Carcinogenicity Studies of Pharmaceuticals [PDF] or [HTML] |
Final |
9/17/2008 |
| S2A Specific Aspects
of Regulatory Genotoxicity Tests for Pharmaceuticals [PDF] |
Final |
4/1996 |
| S2B Genotoxicity: A
Standard Battery for Genotoxicity Testing of Pharmaceuticals [PDF] |
Final |
11/21/1997 |
| S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use [PDF] or [HTML] |
Draft
note* |
3/24/2008 |
| S3A Toxicokinetics:
The Assessment of Systemic Exposure in Toxicity Studies [PDF] |
Final |
3/1995 |
| S3B
Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies [PDF] |
Final |
3/1995 |
| S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent
Toxicity Testing) [PDF] or [Text] |
Final |
Posted 6/25/99 |
S5(R2) Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility
Note: In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined S5 document. The contents of the two guidances were not revised.
- S5A Detection of
Toxicity to Reproduction for Medicinal Products [PDF]
- S5B Detection of
Toxicity to Reproduction for Medicinal Products:
Addendum on Toxicity to Male
Fertility [PDF]
|
Final
Final |
9/1994
4/1996 |
| S6 Preclinical
Safety Evaluation of Biotechnology-Derived Pharmaceuticals [PDF] |
Final |
11/1997 |
| S7A Safety Pharmacology Studies for Human Pharmaceuticals [HTML] or [PDF] |
Final |
7/2001 |
| S7B Nonclinical Evaluation of the Potential for Delayed Ventricular
Repolarization (QT Interval Prolongation) by Human Pharmaceuticals [HTML]
or [PDF] |
Final |
10/19/2005 |
| S8 Immunotoxicity Studies for Human
Pharmaceuticals [HTML] or [PDF] |
Final |
4/12/2006 |
Back to Top
Investigational New Drug Applications
|
Title and Format |
Type |
Issue Date |
| Content and Format of Investigational New Drug
Applications (INDs) for Phase 1 Studies of Drugs [PDF] |
Final |
11/1995 |
Industry Letters
|
Title and Format |
Type |
Issue Date |
| Continuation of a series of
letters communicating interim and informal generic drug policy and guidance.
Availability of Policy and Procedure Guides, and further operational changes to the
generic drug review program [PDF] |
Final |
Posted 3/2/1998 |
| Fifth of a series
of letters providing informal notice about the Act, discussing the statutory
mechanism by which ANDA applicants may make modifications in approved drugs
where clinical data is required [PDF] |
Final |
Posted 3/2/1998 |
| Fourth of a series
of letters providing informal notice to all affected parties about policy
developments and interpretations regarding the Act. Three year
exclusivity provisions of Title I [PDF] |
Final |
Posted 3/2/1998 |
| Implementation of
the Drug Price Competition and Patent Term Restoration Act. Preliminary
Guidance [PDF] |
Final |
Posted 3/2/1998 |
| Implementation
Plan USP injection nomenclature [PDF] |
Final |
Posted 3/2/1998 |
| Seventh of a
series of letters about the Act providing guidance on the "130-day
exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&C [PDF] |
Final |
Posted 3/2/1998 |
| Sixth of a series
of informal notice letters about the Act discussing 3-and 5-year exclusivity
provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act [PDF] |
Final |
Posted 3/2/1998 |
| Supplement to
10/11/1984 letter about policies, procedures and implementation of the Act
(Q&A format) [PDF] |
Final |
Posted 3/2/1998 |
| Third of a series
of letters regarding the implementation of the Act [PDF] |
Final |
Posted 3/2/1998 |
| Year 2000 Letter from Dr.
Janet Woodcock [PDF] |
Final |
10/19/1998 |
Back to Top
Labeling
|
Title and Format |
Type |
Issue Date |
|
Adverse Reactions Section of Labeling for Human
Prescription Drug and Biological Products — Content and Format [HTML] or [PDF] |
Final |
1/18/2006 |
| Clinical Studies Section of Labeling for Human Prescription Drug and
Biological Products — Content and Format [HTML] or [PDF] |
Final |
1/18/2006 |
| Content and Format for Geriatric Labeling [HTML] or [PDF] |
Final |
10/2001 |
| Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products [HTML] or [PDF] |
Draft
note* |
4/6/2007 |
| Contents of a Complete Submission for the Evaluation of Proprietary Names [PDF] or [HTML] |
Draft
note* |
11/24/2008 |
| Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims [PDF] or [HTML] |
Draft
note* |
3/12/2008 |
Labeling for Combined Oral Contraceptives
[PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
3/2/2004 |
| Labeling for Human Prescription Drugs -- Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information [HTML] or [PDF] |
Draft
note* |
5/15/2007 |
Labeling for Human Prescription Drug and Biological Products —
Implementing the New Content and Format Requirements [HTML]
or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
1/18/2006 |
|
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal
Yeast Infections (Vulvovaginal Candidiasis)
[PDF] |
Draft
note* |
6/1998 |
Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor
Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended Prescribing
Informtion for Health Care Providers and Patient Labeling [HTML]
or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
11/15/2005 |
| Public Availability of Labeling Changes in
"Changes Being Effected" Supplements [PDF] or [HTML] Federal Register Notice: [TXT] [PDF] |
Draft
note* |
9/19/2006 |
| Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices [PDF] or [HTML] |
Draft
note* |
6/10/2008 |
| Warnings and Precautions, Contraindications, and Boxed Warning Sections of
Labeling for Human Prescription Drug and Biological Products — Content and
Format [HTML] or [PDF] |
Draft
note* |
1/18/2006 |
Back to Top
Microbiology
|
Title and Format |
Type |
Issue Date |
| Format and Content of the Microbiology Section of an Application* [PDF] |
Final |
1990 |
Modernization Act of 1997
|
Title and Format |
Type |
Issue Date |
| Changes to an Approved NDA or ANDA [HTML] or [PDF] |
Final |
4/2004 |
| Classifying
Resubmissions in Response to Action Letters [PDF] |
Final |
5/14/1998 |
| Enforcement Policy
During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic
Act |
Final |
Withdrawn
9/2008 |
Fast Track Drug Development Programs - Designation, Development, and
Application Review [HTML] or [PDF]
(Posted 7/22/2004)
Appendix 2 [PDF] ; Appendix
3
consisting of Mapp
6020.3 and SOPP
8405;and Appendix
4 [PDF] [Appendices are scanned
copies, which will be replaced by final versions] |
Final |
11/17/1998 |
| Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [PDF] |
Final |
2/2000 |
| Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF] |
Final |
2/2000 |
| Implementation of Section 120 of the Food and Drug Administration
Modernization Act of 1997-Advisory Committees [PDF] |
Final |
10/1998 |
| Implementation of
Section 126 of the Food and Drug Administration Modernization Act of 1997 -
Elimination of Certain Labeling Requirements [PDF] |
Final |
7/1998 |
| Information Program on Clinical Trials for Serious or Life-Threatening
Diseases and Conditions [HTML] or [PDF] |
Final |
3/2002 |
Information Program on Clinical Trials for Serious or Life-Threatening
Diseases and Conditions [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
1/2004 |
| National Uniformity
for Nonpresciption Drugs - Ingredient Listing for OTC Drugs |
Final |
4/1998 |
|
PET Drug Applications - Content and Format for NDAs and ANDAs
[HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]
- Sample formats for chemistry,
manufacturing, and controls sections [PDF]
- Sample formats for labeling [PDF]
- Sample formats for Form FDA 356h [PDF]
- Sample formats for user fee Form FDA 3397 [PDF]
|
Draft
note* |
3/7/2000 |
| Providing Clinical
Evidence of Effectiveness for Human Drug and Biological Products [PDF] |
Final |
5/14/1998 |
| Qualifying for Pediatric Exclusivity Under Section 505A of the Federal
Food, Drug, and Cosmetic Act [HTML] or [PDF]
|
Final |
9/1999 Posted 7/27/1999 |
| Repeal of Section
507 of the Federal Food, Drug and Cosmetic Act [PDF] |
Final |
Revised
5/1998 |
| Reports on the Status of Postmarketing Study Commitments — Implementation
of Section 130 of the Food and Drug Administration Modernization Act of 1997 [HTML]
or [PDF] |
Final |
2/15/2006 |
| Standards for
Prompt Review of Efficacy Supplements [PDF] |
Final |
5/15/1998 |
| Submission of
Abbreviated Reports and Synopses in Support of Marketing Applications [PDF] |
Final |
8/1998 |
| Submitting and Reviewing Complete Responses to Clinical Holds
(Revised) [HTML] or [PDF] |
Final |
10/2000 |
Back to Top
Over-the-Counter (OTC) Guidances
|
Title and Format |
Type |
Issue Date |
| Enforcement Policy on Marketing
OTC Combination Products (CPG 7132b.16) [PDF] |
Final |
5/1984 |
| General Guidelines
for OTC Combination Products [PDF] |
Final |
11/1978 |
| Labeling OTC Human Drug Products -- Questions and Answers [PDF] or [HTML] |
Final |
1/2/2009 |
Labeling OTC Human Drug Products -Submitting Requests for Exemptions and
Deferrals [HTML] or
[PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
12/2000 |
Labeling OTC Human Drug Products (Small Entity Compliance Guide)
[PDF]
Federal Register Notice: [ TXT ] [ PDF ]
|
Draft
note* |
12/2004 |
Labeling OTC Human Drug Products Updating Labeling in ANDAs [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ]
- Additional
examples 1 [PDF] (3/19/2001)
- Additional
examples 2 [PDF] (3/26/2001)
- Additional
examples 3 [PDF] (3/26/2001)
| Draft
note* |
2/21/2001 |
Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs [HTML]
or [PDF]
Example Drug Facts Labels
- Acetaminophen 120 mg in a Suppository Dosage Form [PDF]
- Acetaminophen 325 mg in a Suppository Dosage Form [PDF]
- Acetaminophen 650 mg in a Suppository Dosage Form [PDF]
- Cimetidine 200 mg in a Tablet Dosage Form [PDF]
- Clemastine Fumerate 1.34 mg in a Tablet Dosage Form [PDF]
- Doxylamine Succinate 25 mg Tablet Dosage Form [PDF]
- Ibuprofen 200 mg in a Tablet/Capsule Dosage Form [PDF]
- Loperamide HCl in a Liquid Dosage Form [PDF]
- Loperamide HCl in a Tablet/Caplet Dosage Form [PDF]
- Miconazole Nitrate Vaginal Products [PDF]
- Minoxidil Topical Solution 2% for Men and Women [PDF]
- Minoxidil Topical Solution 5% for Men [PDF]
- Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form [PDF]
- Pseudoephedrine HCl Extended-Release Tablets 120 mg [PDF]
|
Final |
10/2002 |
| Labeling OTC Human Drug Products Using a Column Format [HTML] or [PDF] |
Final |
12/2000 |
| Labeling OTC Skin Protectant Drug Products [PDF] or [HTML] |
Draft
note* |
8/4/2008 |
| Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1 [PDF] |
Draft
note* |
12/8/2008 |
Time and Extent Applications [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
2/2004 |
| Upgrading Category III Antiperspirants to Category I (43 FR
46728-46731) [PDF] |
Final |
10/1978 |
Back to Top
Pharmacology/Toxicology
|
Title and Format |
Type |
Issue Date |
| Animal Models — Essential Elements to Address Efficacy Under the Animal Rule [PDF] |
Draft
note* |
1/16/2009 |
| Carcinogenicity Study Protocol Submissions [HTML] or [PDF] |
Final |
5/22/2002 |
| Content and Format of INDs for Phase 1 Studies of Drugs, Including
Well-Characterized, Therapeutic, Biotechnology-Derived Products [HTML] or [PDF] |
Final |
10/2000 |
Developing Medical Imaging Drug and Biological Products
- Part 1: Conducting Safety Assessments [HTML]
or [PDF]
|
Final |
6/17/2004 |
| Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for
Therapeutics in Adult Healthy Volunteers [HTML] or [PDF] |
Final |
7/21/2005 |
| Exploratory IND Studies [HTML] or [PDF] |
Final |
1/12/2006 |
|
Format and Content
of the Nonclinical Pharmacology/Toxicology Section of an Application*[PDF] |
Final |
2/1987 |
| Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches [PDF] or [HTML] |
Draft
note* |
12/15/2008 |
| Immunotoxicology Evaluation of Investigational New Drugs [HTML]
or [PDF] |
Final |
10/2002 |
Integration of Study Results to Assess Concerns about Human Reproductive
and Developmental Toxicities [PDF]
(Issued , Posted 11/9/2001)
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
11/2001 |
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic
Radiopharmaceuticals [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
6/17/2005 |
| Nonclinical
Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the
Transmission of Sexually Transmitted Diseases (STD) and/or for the Development
of Drugs Intended to Act as Vaginal Contraceptives |
Final |
10/96
Updated
7/2005 |
|
Nonclinical Safety Evaluation of Drug or Biologic Combinations
[HTML] or [PDF] |
Final |
3/14/2006 |
| Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route [PDF] or [HTML] |
Draft
note* |
3/7/2008 |
| Nonclinical Safety Evaluation of Pediatric Drug Products [HTML]
or [PDF] |
Final |
2/14/2006 |
| Nonclinical Studies for the Safety Evaluation of
Pharmaceutical Excipients [HTML]
or [PDF] |
Final |
05/18/2005 |
| Photosafety Testing [HTML] or [PDF] |
Final |
5/7/2003 |
| Recommended Approaches to Integration of Genetic Toxicology Study Results
[HTML] or [PDF] |
Final |
1/3/2006 |
|
Reference Guide
for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the
Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity
Prior to Phase I Clinical Studies [PDF] |
Final |
3/2/1998 |
Safety Testing of Drug Metabolites [PDF] or [HTML]
|
Final |
2/14/2008 |
| Single Dose Acute
Toxicity Testing for Pharmaceuticals [PDF] |
Final |
8/1996 |
Statistical Aspects of the Design,
Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of
Pharmaceuticals [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
5/2001 |
Back to Top
Procedural
|
Title and Format |
Type |
Issue Date |
| 180-Day Generic
Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug,
and Cosmetic Act [PDF] |
Final |
6/1998 |
Applications Covered by Section 505(b)(2) [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
10/1999 |
Certifications To Accompany Drug, Biological Product, and Device
Applications/Submissions:Compliance with Section 4020) of
The Public Health Service Act,
Added By Title VIII of The Food and Drug Administration
Amendments Act of 2007
[PDF] |
Draft
note* |
4/2008 |
| Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act [PDF] |
Draft
note |
1/16/2009 |
| Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administation [PDF] |
Draft
note*
|
12/2006 |
| Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products [PDF] or [HTML] |
Final |
2/22/2008 |
| Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast
Track Products Under PDUFA [HTML] or [PDF] |
Final |
Posted 10/1/2003 |
Continuous Marketing Applications: Pilot 2 – Scientific
Feedback and Interactions During Development of Fast Track Products Under
PDUFA [HTML] or [PDF]
- Paperwork Reduction Act Burden Statement [HTML] or [PDF] (Posted 7/27/2004)
|
Final |
Posted 10/1/2003 |
| Cooperative Manufacturing Arrangements for Licensed Biologics [PDF] of [HTML] |
Final |
12/3/2008 |
| Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the
Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF] |
Final |
Posted 3/27/2000 |
Disclosing Information Provided to Advisory Committees in Connection with
Open Advisory Committee Meetings Related to the Testing or Approval of New
Drugs and Convened by the Center for Drug Evaluation and Research, Beginning
on January 1, 2000 [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
12/1999 |
Disclosure of Conflicts of Interest for Special Government Employees
Participating in FDA Product Specific Advisory Committees [HTML] or
[PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
2/14/2002 |
| Disclosure of Materials Provided to Advisory Committees in Connection with
Open Advisory Committee Meetings Convened by the Center for Drug Evaluation
and Research Beginning on January 1, 2000 [HTML] or [PDF] |
Final |
11/1999 |
| Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate,
and Octisalate — Labeling Enforcement Policy [PDF] or [HTML] |
Final |
6/3/2003 |
| Emergency Use Authorization of Medical Products; Availability [PDF] |
Draft
note* |
7/5/2005 |
| End-of-Phase 2A Meetings [PDF] or [HTML] |
Draft
note* |
9/25/2008 |
| Enforcement Policy
During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic
Act [PDF] |
Final |
11/1998 |
Fast Track Drug Development Programs - Designation, Development, and
Application Review [HTML] or [PDF]
Appendix 2 [PDF] ; Appendix
3
consisting of Mapp
6020.3 and SOPP
8405;and Appendix
4 [PDF]
[Appendices are scanned copies, which will be replaced by final versions
11/18] (Issued 11/17/1998, Posted 11/17/1998) |
Final |
1/12/2006 |
| FDA Export Certicates [HTML]
or [PDF] |
Final |
7/2004 |
| Financial
Disclosure by Clinical Investigators |
Final |
3/27/2001 |
| Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV [PDF] or [HTML] |
Final |
10/17/2006 |
| Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [PDF] |
Final |
2/2000 |
| Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF] |
Final |
2/2000 |
Forms for Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution [HTML] or [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
5/14/2001 |
| Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices U.S. [HTML] |
Final |
1/14/2009 |
| Good Review Management Principles and Practices
for PDUFA Products [HTML] or [PDF] |
Final |
3/2005 |
| Guidance for FDA Staff: The Leveraging Handbook; An Agency
Resource for Effective Collaborations [HTML]
or [PDF] |
Final |
Revised 6/2003 |
Guidance for Clinical Investigators,
Sponsors, and IRBs
Adverse Event Reporting to IRBs —
Improving Human Subject Protection [PDF] or [HTML] |
Final |
1/14/2009 |
Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention
When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability [PDF] |
Draft
note* |
12/2/2008 |
How to Comply with the Pediatric Research Equity Act [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
9/7/2005 |
| Implementation of Section 120 of the Food and Drug Administration
Modernization Act of 1997-Advisory Committees [PDF] |
Final |
10/1998 |
| Implementation of
Section 126 of the Food and Drug Administration Modernization Act of 1997 -
Elimination of Certain Labeling Requirements [PDF] |
Final |
7/1998 |
| Independent Consultants for Biotechnology Clinical Trial Protocols - [HTML]
or [PDF] |
Final |
8/18/2004 |
Information Program on Clinical Trials for Serious or Life-Threatening
Diseases and Conditions [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
1/2004 |
| Information Program on Clinical Trials for Serious or Life-Threatening
Diseases and Conditions [HTML] or [PDF] |
Final |
3/2002 |
| Information Request and Discipline Review Letters Under the Prescription
Drug User Fee Act [HTML]
or [PDF] |
Final |
11/2001 |
Information Sheet Guidance
for Sponsors, Clinical
Investigators, and IRBs
Frequently Asked Questions -
Statement of Investigator
(Form FDA 1572) [PDF] |
Draft
note* |
7/29/2008 |
| Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document [HTML] or [PDF] |
Draft
note* |
7/2/2007 |
| Integrated Summary of Effectiveness [PDF] or [HTML] |
Draft
note* |
7/26/2008 |
| Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance
Date and Submission of New Applications [HTML] or [PDF] |
Final |
7/2001 |
| National Uniformity
for Nonpresciption Drugs - Ingredient Listing for OTC Drugs [PDF] |
Final |
4/1998 |
PET Drug
Applications - Content and Format for NDAs and ANDAs or [PDF] (Issued ,
Posted 3/7/2000)
Federal Register Notice: [ TXT ] [ PDF ]
- Sample formats for
chemistry, manufacturing, and controls sections [PDF]
- Sample formats for
labeling [PDF]
- Sample formats for Form
FDA 356h [PDF]
- Sample formats for
user fee Form FDA 3397 [PDF]
| Draft
note* |
3/7/2000 |
Pharmacogenomic Data Submissions [HTML]
or [PDF]
- Examples of Voluntary Submissions or Submissions
Required Under 21 CFR 312, 314, or 601 [HTML]
or [PDF]
|
Final |
3/2005 |
| Pharmacogenomic Data Submissions — Companion Guidance [PDF] or [HTML] |
Draft
note* |
8/28/2007 |
| Postmarketing Adverse Even Reporting for Medical products and Dietary Supplements During an Influenza Pandemic [PDF] or [HTML] |
Draft
note* |
12/15/2008 |
Postmarketing
Safety Reporting for Human Drug and Biological Products Including Vaccines [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
3/9/2001 |
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies [HTML]
or [PDF]
- KI in Radiation Emergencies-Questions and Answers [HTML]
or [PDF]
|
Final |
12/10/2001
12/23/2002 |
| Potassium Iodide Tablets - Shelf Life Extension [PDF] |
Final |
3/8/2004 |
| Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees [PDF] |
Draft
note* |
3/21/2007 |
| Process for Handling
Referrals to FDA Under 21 CFR 50.54 Additional Safeguards for
Children in Clinical Investigations [PDF] |
Final |
12/22/2006 |
| Protecting the Rights, Safety, and Welfare of Study Subjects- Supervisory Responsibilities of Investigators [PDF] |
Draft
note* |
6/7/2007 |
| Qualifying for Pediatric Exclusivity Under Section 505A of the Federal
Food, Drug, and Cosmetic Act [HTML] or [PDF] |
Final |
9/1999 |
| Reduction
of Civil Money Penalties for Small Entities |
Final |
3/20/2001 |
| Refusal to File [PDF] |
Final |
7/12/1993 |
| Repeal of Section
507 of the Federal Food, Drug and Cosmetic Act [PDF] |
Final |
Revised 5/1998, |
| Reports on the Status of Postmarketing Study Commitments — Implementation
of Section 130 of the Food and Drug Administration Modernization Act of 1997 [HTML]
or [PDF] |
Final |
2/15/2006 |
| Special Protocol Assessment [HTML] or [PDF] |
Final |
5/2002 |
| Standards for
Prompt Review of Efficacy Supplements [PDF] |
Final |
5/15/1998 |
| Submission of Patent Information for Certain Old Antibiotics [PDF] |
Draft
note* |
11/28/2008 |
| Submitting and Reviewing Complete Responses to Clinical Holds
(Revised) [HTML] or [PDF] |
Final |
10/2000 |
| Submitting
Debarment Certification Statements [PDF] |
Draft
note* |
10/2/98 |
Submitting Marketing Applications According to the ICH/CTD Format: General
Considerations [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
9/5/2001 |
| Target Product Profile -- A Strategic Development Process Tool [PDF] or [HTML] |
Draft
note* |
3/29/2007 |
The
Use of Clinical Holds Following Clinical Investigator Misconduct [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
4/2002 |
| Tropical Disease Priority Review Vouchers [PDF] or [HTML] |
Draft
note* |
10/21/2008 |
| Useful Written Consumer Medication Information (CMI) [HTML]
or [PDF] |
Final |
7/17/2006 |
| Using a Centralized IRB Review Process in
Multicenter Clinical Trials [HTML]
or [PDF] |
Final |
3/15/2006 |
| Waiver of IRB Requirements for Drug and Biological Product Studies [PDF] |
Final |
1/2006 |
| Women and Minorities
Guidance Requirements [PDF] |
Final |
7/20/1998 |
Back to Top
Small Entity
|
Title and Format |
Type |
Issue Date |
| Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation
— Small Entity Compliance Guide [PDF] |
Final |
11/7/2001 |
Labeling OTC Human Drug Products (Small Entity Compliance Guide)
[PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
12/2004 |
User Fees
|
Title and Format |
Type |
Issue Date |
|
Attachment G -- Draft
Interim Guidance Document for Waivers of and Reductions in User Fees [PDF] |
Draft
note* |
7/16/1993 |
| Classifying
Resubmissions in Response to Action Letters [PDF] |
Final |
5/14/1998 |
| Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act [HTML] or [PDF] |
Final |
6/1999 |
Guidance for Industry and FDA Staff: Application User Fees for Combination Products [PDF] |
Final |
4/2005 |
| Information Request and Discipline Review Letters Under the Prescription
Drug User Fee Act [HTML]
or [PDF] |
Final |
11/2001 |
| Submitting Separate Marketing Applications
and Clinical Data for
Purposes of Assessing User Fees [HTML]
or [PDF] |
Final |
12/30/2004 |
User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR [PDF] or [HTML] (Issued , Posted 2/7/2007)
|
Final |
2/7/2007 |
Also see Current Good Manufacturing Practice Regulations
Enforcement
of the Postmarketing Adverse Drug Experience Reporting
Regulations
(Posted 8/11/1997)
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Date updated: January 16, 2009 |
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