FDA Modernization Act of 1997
CDER-Related Documents
Contents by Section
Sections 103/104 - Reauthorization
of PDUFA
- Classifying Resubmissions in Response to Action Letters (Guidance) - (NOA) [Text] or [PDF]
- Submitting and Reviewing Complete Responses to Clinical Holds (Guidance) - (NOA)
[Text] or [PDF]
For more information, see Prescription
Drug User Fee Act Related Documents
Section 111 - Pediatric Studies
of Drugs
- Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and
Cosmetic Act [HTML] or [PDF] (Issued 9/1999, Posted 10/4/1999) -
(NOA) [Text] or [PDF]
- List of Approved Drugs for which Additional Pediatric Information May Produce Health
Benefits in the Pediatric Population (Final List) - (NOA) [Text] or [PDF]; (Draft List) - (NOA)
[Text] or [PDF]
For more information, see the CDER Pediatric Medicine Page and the FDA Dockets Page
Section 112- Fast Track Drug Development
- Fast Track Drug Development Programs – Designation, Development, and Application
Review: (Guidance)
- (NOA) [Text] or [PDF]; Appendix 2
;
Appendix 3 consisting of Mapp 6020.3 and SOPP 8405; and Appendix 4
[Appendices are scanned copies, which will be replaced by final versions 11/18] (Issued
11/17/1998, Posted 11/17/1998)
Section 113 -
- Guidance for Industry on Information Program on Clinical Trials for
Serious or Life-Threatening Diseases and Conditions [PDF]
(Issued 3/2002, Posted 3/18/2002) - (NOA) [TXT]
or [PDF]
Section 115 -
Women and Minorities Guidance Requirements
- Women and Minorities Guidance Requirements
(Issued 7/20/1998, Posted 11/25/1998)
Section 116 - Manufacturing Changes for Drugs
- FDAMA Section 116 Implementation Information [HTML]
or [PDF] (Posted 8/13/1999)
- Supplements and Other Changes to an Approved Application (Proposed Rule) published 6/28/99.
- Changes to an Approved NDA or ANDA [PDF]
(Issued 11/1999, Posted 11/19/1999)
Section 117 -
Streamlining Clinical Research on Drugs
- Submitting and Reviewing Complete Responses to Clinical Holds (Guidance) (NOA) [Text] or [PDF]
- Investigational New Drug Applications; Clinical Holds; (Direct Final Rule)
[Text] or [PDF] - (Companion
Proposed Rule) [Text]
- Investigational New Drug Applications; Clinical Holds; Confirmation of Effective Date (Direct
Final Rule) [Text] or [PDF]
(Issued 4/20/99, Posted 5/19/99)
- IND Process and Review Procedures (Including Clinical Holds) (MAPP)
Section 118 -
Abbreviated Reports and Synopses
- Submission of Abbreviated Reports and Synopses in Support of Marketing Applications [HTML] or [PDF]
(Issued 8/1999, Posted 9/13/1999)
Section 119
- Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF]
(Issued 2/2000, Posted 3/6/2000) ] (NOA) [Text] or [PDF]
- Special Protocol Assessment [HTML] or [PDF]
(Issued 5/2002, Posted 5/16/2002) (NOA) [Text]
or [PDF]
Section 120 - Scientific Advisory
Panels
- Implementing Section 120 of the Food and Drug Administration Modernization Act of
1997-Advisory Committees (Guidance) [Wordperfect] or [PDF] - (NOA)
[Text] or [PDF]
Section 121 - PET (Positron
Emission Tomography)
- Current Good Manufacturing Practice For Positron Emission Tomography
Drugs (NOA) [Text]
or [PDF (Preliminary
Draft Proposed Rule) [PDF]
Developing Medical Imaging Drug and Biological Products
(Issued 6/2004, Posted 6/18/2004) (NOA)
[TXT]
[PDF]
-
Part 1: Conducting Safety Assessments [Word]
or [PDF]
-
Part 2: Clinical Indications [Word]
or [PDF]
-
Part 3: Design, Analysis, and Interpretation of Clinical
Studies [Word]
or [PDF]
- PET Drug Products - Current Good Manufacturing Practice (CGMP) (Guidance)
[HTML] or [PDF]
and (NOA) [Text]
or [PDF]
- Preliminary Draft Regulations On Current Good Manufacturing
Practices For PET Drugs (Preliminary Draft Regulation) (9/20/1999) (NOA) [PDF]
- Revocation of Regulation on Positron Emission Tomography Drug Products (Final Rule) [Text] or [PDF]
- Revocation of Certain Guidance Documents on Positron Emission Tomography Drug Products (Notice)
[Text] or [PDF]
For more information, see PET
Page and Dockets Page
Section 122 - Requirements
for Radiopharmaceuticals
Developing Medical Imaging Drug and Biological Products
(Issued 6/2004, Posted 6/18/2004) (NOA)
[TXT]
[PDF]
-
Part 1: Conducting Safety Assessments [Word]
or [PDF]
-
Part 2: Clinical Indications [Word]
or [PDF]
-
Part 3: Design, Analysis, and Interpretation of Clinical
Studies [Word]
or [PDF]
- Open Public Meeting on FDA'S
Draft "Guidance for Industry: Developing Medical Imaging Drugs and Biologics (3/9/99)
- Open Public Meeting Agenda for FDA Public Meeting: Draft Guidance
for Industry: Developing Medical Imaging drugs and Biologics (3/22/99)
- Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring (Proposed
Rule) [Text] or [PDF]
- Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring (Final
Rule) [Text] or [PDF]
(Issued 5/17/99, Posted 5/19/99)
Section 125 - Insulin and Antibiotics
- Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug and
Cosmetic Act; Confirmation of Effective Date (Direct Final Rule) [Text] or [PDF] (Issued
5/17/99, Posted 5/19/99)
- Marketing Exclusivity and Patent Provisions for Certain Antibiotic Drugs (Proposed
Rule) [Text] or [PDF]
(Issued 1/24/2000, Posted 1/24/2000)
- Repeal of Section 507 of the Federal Food, Drug, and Cosmetic Act (Guidance) (NOA)
- Removal of Regulations Regarding Certification of Antibiotic Drugs (Proposed Rule) [Text] or [PDF] -
(Direct Final Rule) [Text] or [PDF]
- Removal of Regulations Regarding Certification of Antibiotic Drugs; Confirmation of
Effective Date (Direct Final Rule) [Text] or [PDF]
- Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of
Insulin (Proposed Rule) [Text] or [PDF] - (Direct Final Rule) [Text] or [PDF]
- Removal of Regulations Regarding Certification of Drugs Composed Wholly or Parly of
Insulin; Confirmation of Effective Date (Direct Final Rule) [Text] or [PDF]
Section 126 -
Elimination of Certain Labeling Requirements
- Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs (Proposed
Rule) ] [Text]
or [PDF] (4/10/2000)
- Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs;
Republication (Proposed Rule) [HTML]
or [PDF] (4/21/2000)
- Implementation of Section 126 of the Food and Drug Administration Modernization Act of
1997 – Elimination of Certain Labeling Requirements (Revised Guidance) - (NOA) [Text] or [PDF]
Section 127 - Pharmacy Compounding
- Additions to the List of Drug Products That Have Been Withdrawn or Removed From the
Market for Reasons of Safety or Effectiveness (Proposed Rule) [Text] or [PDF] 1/5/2000
- Advisory Committees; Pharmacy Compounding Advisory Committee; Establishment (Final
Rule) [Text] or [PDF]
- Bulk Drug Substances to be Used in Pharmacy Compounding; Request for Nominations (Notice)
[Text] or [PDF]
- Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and
Cosmetic Act (Guidance) [Text] or [PDF] - (NOA) [Text] or [PDF]
- FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for Compounding
Because of Reasons of Safety or Effectiveness [HTML] (6/29/2000)
- Federal/State Memorandum of Understanding on Interstate
Distribution of Compounded Drug Products; Draft; Availability (Notice) [Text] or [PDF]
and (Draft MOU) (Issued 1/21/99,
posted 1/21/99)
- Federal/State Memorandum of Understanding on Interstate Distribution of Compounded Drug
Products; Draft; Availability; (Reopening of Comment Period) [Text] or [PDF] (Posted
6/23/99)
- Letter Extending the Comment Period for the Concept Paper
(8/14/2000)
- List of Bulk Drug Substance That May Be Used in Pharmacy Compounding (Notice of
Availability for the Draft Proposed Rule) [Text] or [PDF] and (Draft
Proposed Rule) [PDF] (Issued
10/16/98)--(Proposed Rule) [Text] or [PDF] (Issued 1/7/99)
- List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of
Safety or Effectiveness (Proposed Rule) [PDF]
(10/8/98)
- List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of
Safety or Effectiveness (Final Rule) [Text]
or [PDF] (Updated 3/9/99)
- Request for Nominations for Members on Public Advisory Committees; Pharmacy Compounding
Advisory Committee (Notice) [Text] or [PDF]
Request for Nomination for Members on Public Advisory Committees;
Pharmacy Compounding Advisory Committee [Text] or [PDF] (11/6/2000)
For more information, see the CDER Practice of Pharmacy Compounding Page and the FDA Dockets Page
Section 129 - Sunscreens
- Sunscreen Drug Products For Over-The-Counter Human Use; Final Monograph [Text] or [PDF]
(Posted 5/21/99)
Section 130
- Postmarketing Studies for Approved Human Drug and Licensed Biological Products; Status
Reports. [Text] or [PDF] (10/31/2000)
- Postmarketing Studies for Human Drugs and Licensed Biological Products; Status Reports
[PDF] (Posted
11/30/1999)
- Reports on the Status of Postmarketing Studies - Implementation of
Section 130 of the Food and Drug Administration Modernization Act of 1997
(Posted 4/4/2001) [HTML] or [PDF]
Section 401 -
Dissemination of Information on New Uses
- Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and
Devices (Proposed Rule) [Text] or [PDF]
Section
403 - Approval of Supplemental Applications for Approved Products
- Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (Guidance) - (NOA) [Text] or [PDF]
- Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy
Supplements (Guidance) -
(NOA) [Text] or [PDF]
Section 404 - Dispute Resolution
- Administrative Practices and Procedures; Internal Agency Review of Decisions (Direct
Final Rule) [Text] or [PDF]
- (Proposed Rule) [Text] or [PDF]
- Administrative Practices and Procedures; Internal Review of Decisions (Final
Rule) [Text] or [PDF]
- Formal Dispute Resolution: Appeals Above the Division Level [HTML] or [PDF]
(Issued 2/2000, Posted 3/6/2000) (NOA) [Text] or [PDF]
Section 406(b) - Communicating
with Our Stakeholders
- FDA FDAMA 406(b) Page
- Letter to Our Stakeholders from Dr. Janet Woodcock
- CDER Specific Questions for Stakeholders
- State of the U.S. Drug Regulatory System-August
17, 1998, Janet Woodcock, M.D. (Posted 8/19/98)
Section 410
- Mutual Recognition Agreements and Global Harmonization
- A Plan that Establishes a Framework for Achieving Mutual Recognition of Good
Manufacturing Practices Inspections (Notice) [Text]
or [PDF]
Section
412 - National Uniformity for Nonprescription Drugs and Cosmetics
- National Uniformity for Nonprescription Drugs - Ingredient Listing for OTC Drugs (Guidance) - (NOA) [Text] or [PDF]
Section 413: Food and Drug Administration Study of
Mercury Compounds in Drugs and Food
List of Drugs and Foods that Contain
Intentionally Introduced Mercury Compounds (11/17/1999)
Quantitative and Qualitative Analysis of
Mercury Compounds in the List (11/17/1999)
Center for Drug Evaluation and Research
http://www.fda.gov/cder/fdama/contents.htm
01/06/06