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Dockets beginning in the year: 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 - 1976 | What's New

Year 2003

Docket Number

Title of Docket

2003N-0561
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)

2003Q-0559

Qualified Health Claim: Monounsaturated fatty acids and reduced risk of coronary heart disease (Updated 3/10/04)

2003Q-0547

Health Claim Notification Based on Authoritative Statement: for Whole Grains and Coronary Heart Disease (New 12/10/03)

2003N-0470

Preparation for ICH meetings and ICH 6 Conference in Osaka, Japan, November 9-15, 2003: Public Meeting (New 12/11/03)

2003N-0312

Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds (Updated 9/28/04)

2003Q-0401

Qualified Health Claim (QHC) OMEGA-3 Fatty Acids and Coronary Heart Disease Health Claim (Updated 5/25/04)

2003N-0338

Obesity (Updated 4/27/04)

2003N-0281

SARS Diagnostics: Scientific and Regulatory Challenges (Updated 7/29/03)
2003P-0274
In Re Tier 1 Initial Approval Program (Updated 10/5/04)

2003N-0207

Preparation for ICH Meetings in Brussels, Belgium, and ICH 6 Conference in Osaka, Japan: Public Meeting (New 7/29/03)

2003N-0203

Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical, and Regulatory Challenges; Public Workshop (Updated 7/30/03)

2003N-0168

Current Status of Useful Written Prescription Drug Information for Consumers; Public Meeting - Transcript Only (New 11/25/03)

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  4/16/03)

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Page updated October 7, 2004 jb

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