Dockets

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

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Draft Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability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Draft Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency (New 6/6/05)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)

2003D-0061

Guidance for Industry:  Comparability Protocols -- Chemistry,  Manufacturing, and Controls Information  (New  3/17/03)

2003D-0060

Guidance for Industry:  Part 11, Electronic Records; Electronic Signatures -- Scope and Application  (Updated  7/03/03)

2003N-0059

Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach  (Updated  1/3/05)