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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 |
|
Year
2003 |
|
Docket Number |
Title of Docket |
513(f) Reclassification Petition for In Vitro Diagnostics for Anti-Hepatitis A Virus IgM and Total Antibodies (New 8/24/07) | |
Orthopedic Devices; Effective Date of the
Proposed Requirement for Premarket Approval of the Hip Joint Metal/Polymer
or Ceramic/Polymer Semi-Constrained Resurfacing Cemented Prosthesis
(New 5/10/04) | |
Qualified Health
Claim: Monounsaturated Fatty Acids and Reduced Risk of Coronary Heart
Disease (Updated 3/10/04) | |
Compliance Policy Guide Sec. 110.310 Prior
Notice of Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (Updated
6/8/05) | |
Health Claim Notification
Based on Authoritative Statement: for Whole Grains and Coronary Heart
Disease (New 12/10/03) | |
(Formerly 03N-0496) Food Labeling: Health Claims;
Dietary Guidance - selected documents (New
09/28/05) | |
2003D-0478 |
Guidance on Marketed Unapproved Drugs Compliance Policy Guide |
Preparation for ICH
meetings and ICH 6 Conference in Osaka, Japan, November 9-15, 2003:
Public Meeting (New 12/11/03) | |
Denovo Reclassification Petition for West Nile Virus IgM Capture ELISA (New 8/23/07) | |
Qualified Health Claim (QHC) OMEGA-3 Fatty
Acids and Coronary Heart Disease Health Claim (Updated
11/29/04) | |
Draft Guidance for Industry: PAT - A Framework
for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability | |
Amend Approval for a Nonperscription Form
of Priolosec (Omeprazole Magnesium) (New 12/9/04) | |
Galderma Product, Solage Containing 2%
Mequinol, and 0.01% Tretinoin, NDA 20-922 can be Formulated as a Topical
Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol
as an ANDA (New 12/29/04) | |
Obesity (Updated
4/27/04) | |
Medical Devices; Exception from General
Requirements for Informed Consent (Updated 8/17/06) | |
Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing (New 8/23/07) | |
Discussion of Animal Feed Safety System
(AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture
and Distribution of Animal Feeds (Updated 7/1/05) | |
Classification of Transscutaneous Air Conduction Hearing Aid (New 8/22/07) | |
SARS Diagnostics: Scientific and Regulatory
Challenges (Updated 7/29/03) | |
In Re Tier 1 Initial Approval Program (Updated
10/5/04) | |
Draft Guidance for Industry: Channels
of Trade Policy for Commodities With Residues of Pesticide Chemicals,
for Which Tolerances Have Been Revoked, Suspended, or Modified by the
Environmental Protection Agency (New 6/6/05) | |
Preparation for ICH
Meetings in Brussels, Belgium, and ICH 6 Conference in Osaka, Japan:
Public Meeting (New 7/29/03) | |
Exocrine Pancreatic Insufficiency Drug Products (New 10/31/07)
| |
Draft Guidance for Industry on Exocrine
Pancreatic Insufficiency Drug Products; Availability (New
9/21/05) | |
Exocrine Pancreatic Insufficiency Drug Products (New 10/30/07) | |
Innovative Systems for Delivery of Drugs
and Biologics: Scientific, Clinical, and Regulatory Challenges; Public
Workshop (Updated 7/30/03) | |
Follow-On Approval of Therapeutic Protein
Products (Updated 7/13/06) | |
Current Status of
Useful Written Prescription Drug Information for Consumers; Public Meeting
- Transcript Only (New 11/25/03) | |
Removing Serzone (NEFAZODONE) from the
Market Bristal-Myers | |
Withhold Approval of Generic Lovenox (enoxaparin
sodium injection) (Updated 9/7/07) | |
Guidance for Industry: Comparability
Protocols -- Chemistry, Manufacturing, and Controls Information | |
Guidance for Industry: Part 11, Electronic
Records; Electronic Signatures -- Scope and Application | |
Pharmaceutical cGMPs for 21st Century:
A Risk-Based Approach |
Page updated October 31, 2007 kk
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