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Dockets beginning in the year: 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 - 1976 | What's New |
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Year
2004 |
|
Docket No. |
Title of Docket |
Overall Benefit to Risk Considerations for COX-2
Selective Nonsteroidal Anti-Inflammatory Drugs and Related Agents (New
5/5/05) | |
ANDA for a Generic Version of Efudex Cream(fluorouracil)
Cream (Updated 8/9/06) | |
Nonclinical and Clinical Datasets; Notice of Pilot
Project (New 3/22/05) | |
Draft Guidance for Industry on and as: Pharmaceutical
Solid Polymorphism; Chemistry, Manufacturing, and Controls Information | |
Laser Light Show (New 12/16/04) | |
Agency Information Collection Activities; Proposed
Collection; Medwatch: the FDA Medical Projects Reporting Program; Comment
Request (New 3/22/05) | |
Agency Information Collection Activities; Proposed
Collection; Comment Request; Format and Content Requirements for Over-the-Counter
(OTC) Drug Product Labeling (New 3/8/05) | |
Medical Devices; Medical Device Reporting (New
6/2/05) | |
Generic Fluticasone Propionate Nasal Spray Products
Meet the Same High Standards of Quality as GSK's Brand-name Product
Lonase (Updated 8/13/07) | |
Off Label Drug Use for CYTOTEC (Updated
6/20/06) | |
180-Day Exclusivity for Ipratropium Bromide and Albuterol
Sulfate Inhalation Solution (New 6/1/05) | |
Cottage Cheese Deviating from Identity Standard; Temporary Permit for Market Testing (New
8/24/07) | |
Stay approval of any ANDAs submitted by Ivax Pharmaceuticals,
Inc., CorePharma LLC, or any other party for which CollaGenex's Periostat
(doxycycline hyclate 20 mg) is the reference listed drug unless that
ANDA's bioequivalence study or studies include female subjects (5/31/05) | |
Agency Information Collection Activities: Proposed
Collection; Comment Request; 2005 Food Safety Survey (New
6/7/05) | |
To Amend Regulation Update Estrogens Increase the
Risk of Endometrial Cancer Prescribing Info of All Strengths of Premarin
Tablets (New 5/20/05) | |
ANDA for Methacholine Chloride 1280 mg/vial (New
5/22/06) | |
Live & Perishable Fish & Fishery Products
for Export to the European Union and the European Free Trade Association
(New 2/28/05) | |
2004D-0484: Guidance for Industry on the Role of
HIV Drug Resistance Testing in Anteiretroviral Drug Development (New
3/11/05) | |
Guidance for FDA Review Staff and Sponsors: Content
and Review of Chemistry, Manufacturing, and Control (CMC) Information
for Human Gene Therapy Investigational New Drug Applications (INDS)
(New 3/3/05) | |
Vitamin D and Calcium and Reduced Risk of Osteoporosis
(New 10/27/05) | |
Food Labeling: Prominence of Calories (New
8/23/05) | |
Guidance for Industry on 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
(New 2/28/05) | |
Guidance for Industry on Pharmacokinetics in Pregnancy
Study Design, Data Analysis and Impact on Dosing and Labeling (New
3/22/05) | |
Reclassification of the Buechel-Pappas Unconstrained
Ankle Prosthesis (Updated 9/05/07)
| |
Food Labeling: Serving Sizes of Products that Can
Reasonably be Consumed at One Eating Occasion; Updating of Reference
Amounts Customarily Consumed; Approaches for Recommending Smaller Portion
Sizes (New 6/10/05) | |
Scientific
Considerations Related to Developing Follow-On Protein Products (New
4/25/06) | |
Dietary Supplements; Premarket Notification for
New Dietary Ingredient Notifications; Public Meeting (New
12/9/04) | |
ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable
Tablets (New 6/9/06) | |
Compliance Policy Guide Sec. 560.400 - "Imported
Milk and Cream Federal Import Milk Act (CPG7119.05)" (Updated
5/31/05) | |
DERMA-SMOOTHE/FS(fluocinolone acetonide 0.01% topical oil) (Updated 9/7/07)
| |
Guidance for Industry on Quality Systems Approach
to Pharmaceutical Current Good Manufacturing Regulations (Updated
3/3/05) | |
Guidance for Industry on Computerized Systems used
in Clinical Trials (Updated 3/3/05) | |
Second Annual Stakeholder Meeting on the Implementation of the
Medical Device User Fee and Modernization Act of 2002 Provisions,
Public (New 1/13/05)
| |
Regulatory Site Visit Training Program (New
12/9/04) | |
Reject New Drug Application 21-695 | |
Food Labeling: Safe Handling Statements: Labeling
of Shell Eggs (New 6/7/05) | |
International Conference on Harmonisation; Draft
Guidance on S7B Nonclincial Evaluation of the Potential for Delayed
Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals | |
International Conference on Harmonisation; Draft
Guidance on E14 Clinical Evaluation of QT/QTC Interval Prolongation
and Proarrhythmic Potential for N0n-Antiarrhythemic Drugs | |
Recommendations for the Early Food Safety Evaluation
of New Non-Pesticidal Proteins Produced by Bioengineered Plants Intended
for Food Use (New 3/22/05) | |
Amend Food Additive Regulations in 172.380 Vitamin
D3 to Permit the Use of Vitamin D3 in Cheese and Cheese Products at
a Level Above That Permitted Under 184.1950 Vitamin D (New
10/05/04) | |
ANDA Suitability
for Ferrlecit Injection 5 ml/62.5 mg of elemental iron (New
04/26/2006) | |
Suitability Petition for (New Strength) Methacholine
Chloride 1280 mg/vial (New
05/22/2006) | |
Request for Advisory Opinion (21 CFR 808.5) or Exemption (21 CFR 808.1,808.10); Regarding Automatic External Defibrillators (New
8/24/07)
| |
Scientific Considerations Related to Developing Follow-on
Protein Products (Updated 6/2/06) | |
Citizen Petition Requesting Certain Actions with
Respect to Vaccines and Other Drug Products, Containing Added Mercury,
in Order to Reduce the Health Risk to Susceptible Fetuses, Newborns,
Children, Adolescents and Adults (Updated 6/11/07)
| |
ANDA For Fluticasone Propionate Nasal Spray, 50 MCG
(New 5/27/05) | |
Hospital Bed System Dimensional Guidance to Reduce
Entrapment (Updated 6/8/06) | |
Refuse to file Abbreviated New Drug Application (ANDA)
for the Combination Drug Amlodipine Besylate-benazepril Hydrochloride
(amlodipine-benazepril) (New 8/4/06) | |
Subpart D IRB Referral, Effects of a Single Dose
of Dextroamphetamine in Attention Deficit Hyperactivity Disorder; a
Functional Magnetic Resonance Study (Updated 9/20/05)
| |
Suicidality in Clinical Trials for Antidepressant
Drugs in Pediatric Patients (Updated 9/15/04) | |
Request Public Hearings Regarding the Sales, Distribution
and Use of Hand-held Doppler Fetoscopes (New 6/15/06) | |
Civil Money Penalty Re: Ecumed Health Group, Inc.
(New 3/3/05) | |
Refrain from Approving Certain Applications
Submitted Under Section 505(B)(2) of the FDCA that Rerference Depakote
(Divalproex Sodium Delayed-Release Tablets) (Updated
8/10/06) | |
Nutrient Content Claims for Carbohydrates (New
2/25/05) | |
Nutrient Content Claims for the Carbohydrate Content of Food (Updated
2/25/05)
| |
Nutrient Content Claim:
DefineTerms Low Carbohydrate, Reduced Carbohydrate, Reduced Carbohydrate
and Carbohydrate Free (Updated 8/14/06) | |
Waivers of In Vivo Demonstration of Bioequivalence
of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type
A Medicated Articles (New 10/05/04) | |
Laser Light Show (New 1/25/05) | |
Initiate Proceedings to Permit Computerized Thermal
Iimaging, Inc. (CTI) to Supplement the Administrative Record in Connection
with CTIS Premarket Approval Application in P010035 (New
1/25/05) | |
Determine that Drying Lotion, a Topical Acne Drug
Products for Over the Counter Human Use, can Contain in Combination
Both Sulfur (10.0%) and Salicylic Acid (2.0%) as the Active Ingredients
(New 1/25/05) | |
Notice Announcing Publication of the Report to Congress
Entitled "Plan for the Transfer of Responsibility for Medicare
Appeals" and Soliciting Comments (New 8/09/04) | |
Recordkeeping Requirements for Human Food and Cosmetics
Manufactured from Processed with, or Otherwise Containing Material from
Cattle (New 10/04/04) | |
Stimulating Innovation in Medical Technologies(Updated
12/22/04) | |
2004P-0231: Deny Approval of NDA 21-426 for Ominitrop
5.8 mg Somatropin [rDNA origin] for Injection, Lyophilized Powder and
Diluent with Preservative (New 05/31/2006)
| |
Whole Grain Descriptive Claims (Updated
5/1/06) | |
Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 Section 107(F) B (Updated 9/15/04) | |
Nutrient Content Claims: DHA, PEA, and ALA (Omega-3-Fatty
Acids) (New 12/9/04) | |
Public Information Regulations (New
10/25/04) | |
Pandemic Influenza Preparedness and Response Plan
(New 11/10/04) | |
Guidance: Clinical Trial Design for Hip Replacement
Systems (New 5/10/04) | |
Furan in Food; Thermal Treatment (New
6/23/05) | |
Qualified Health Claim (QHC); Lycopene,
Tomatoes and Cancer (Updated 12/28/05) | |
Guidance for Industry on Good Pharmacovigilance
Practices and Pharmacoepidemiologic Assessment (New
7/20/05) | |
Guidance for Industry on Development and
Use of Risk Minimization Action Plans (New 7/20/05) | |
Guidance for Industry on Premarketing
Risk Assessment (New 7/20/05) | |
Nutrient Content
Claim: Expand the Definition of Lean (New
4/27/04) | |
Critical Path Initiative (Updated
11/16/04) | |
Qualified Health
Claim (QHC): Lutein and Eye Diseases (Updated
12/27/05) | |
Intervet Inc. is Requesting Permission to File an ANADA for a Generic Intravaginal Progesterone Insert for Cattle that Differs from the Pioneer Product (EAZI-BREED TM CIDR; NADA 141-200 in Strength (New
8/24/07) | |
Standards for 'Similarity' or 'Sameness'
of Biotechnology-derived Products (Updated 7/12/06) | |
Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest
Priority Topics for Research (Updated 7/13/04) | |
Exemption from the Medical Devices Tracking Requirements
for Heartstream automated External Defibrillators (New
12/02/04) | |
Valley Forge Composite Technologies Explosive Detection
Systems (New 12/16/04) | |
ANDA Suitability for Oxycodone Hydrochloride Capsules
for Oral administration, 5 mg, 10 mg, 20 mg, and 30 mg. (New
6/2/05) | |
Qualified Health
Claim (QHC): Soy Protein and Cancer (Updated
8/5/05) | |
Qualified Health Claim (QHC): Chromium
Picolinate and Diabetes (Updated 12/1/04) | |
Petitioner Requests the Commissioner to Determine that NDA 19-44, Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for Safety or Effectiveness Reasons (New
8/24/07) | |
Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling (Updated 7/16/04) | |
Part II, Electronic Record; Electronic
Signatures; Public Meeting (Updated 9/13/04) | |
Prescription Drug Importation; Public
Meeting (Updated 7/13/04) | |
Nutrient Content Claim: Carbohydrate
Content in Food (Grocery Manufactures of America) (New
3/12/04) | |
Nutrient Content Claim: Carbohydrate
Content in Food (ConAgra Foods) (New 3/1/04) | |
Nutrient Content Claim: Carbohydrate
Content in Food (Kraft Foods North America Inc) (Updated
5/4/05) | |
Qualified Health Claim (QHC): Calcium
and Kidney/Urinary Stones (Updated 10/19/04) | |
Qualified Health Claim (QHC): Calcium
and Bone Fractures (Updated 1/31/05) | |
Qualified Health Claim (QHC): Calcium
and Menstrual Disorders (Updated 9/15/05) | |
Qualified Health Claim (QHC): Calcium
and Hypertension (Updated 11/15/05) | |
Qualified Health Claim (QHC): Calcium
and Various Cancers (Updated 10/21/04) | |
Qualified Health Claim (QHC): Green Tea
and Reduced Risk of Cancer (Updated 6/21/05) | |
BSE Risk Materials in Foods and Cosmetics (New
11/8/04) | |
Oxandrolone and Widely used Anti-coagulant Durgs
Containing the Active Drug Warfarin (Updated 5/3/06) | |
Qualified Health Claim (QHC) for Eggs
with Enhanced Omega-3 Fatty Acid Content and a Balanced 1:1 Ratio of
Omega-3/Omega-6 Fatty Acids and Reduced Risk of Heart Disease and Sudden
Fatal Heart Attack (Updated 5/4/04) | |
Health Claim Petition: Glucosamine Sulfate
and Osteoarthritis (Updated 9/7/05) | |
Health Claim Petition: Glucosamine and Chondroitin
Sulfate and Osteoarthritis (Updated 11/24/04) | |
Issue a Written Opinion Stating that Bio-Rad's Longstanding Practice, Previously Accepted by the Agency, of Developing Unified, Truthful Labeling for Domestic and International Sales of its Control Products is Lawful (New 5/23/07) | |
Requests that the Commissioner of Food and Drug Admination Determine that Astra Zenecal LP's Dyclone(dyclonine hydrochloride) Topical Solution 0.5% and 1.0%(NDA 9-925) was Voluntarily withdrawn or withheld from sale for Reasons Other than Safety or Efficacy (New
8/24/07) | |
Factor VIII Inhibitors,
Public Workshop (New 7/15/04) | |
Human Subject Protection; Foreign Clinical
Studies Not Conducted Under an Investigational New Drug Application
(New 1/7/05) | |
Deny Approval of any New Drug Application
(NDA) for Recombinant Salmon Calcitonin (RESCT) Nasal Spray (Updated
10/12/05) |
Page updated September 7, 2007 kk
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