FDA Application
Federal Register
Friday September 5, 2003
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FDA Federal Register Documents
NOTICES-FINAL GUIDANCES
Docket No. 03D-0060, CDER 200399. Guidance for Industry on Part 11, Electronic Records; Electronic Signatures--Scope and Application; Availability. Pages 52779-52781 [FR Doc. 03-22574] [TXT] [PDF] [PRE-PUB]
NOTICES-DRAFT GUIDANCES
Docket No. 03D-0385, CBER 200338. Draft Guidance for Industry: Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information; Availability. Pages 52776-52777 [FR Doc. 03-22577] [TXT] [PDF] [PRE-PUB] Comments December 4, 2003
Docket No. 03D-0386, CDER 2003131. Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice; Availability. Pages 52777-52779 [FR Doc. 03-22575] [TXT] [PDF] [PRE-PUB] Comments on draft guidance March 5, 2004 Comments on Collection of Information November 4, 2003
Docket No. 03D-0380, CDER 2003136. Draft Guidance for Industry: Process Analytical Technology--A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance; Availability. Pages 52781-52782 [FR Doc. 03-22578] [TXT] [PDF] [PRE-PUB] Comments November 5, 2003
Docket No. 03D-0382, CDER 1997112. Draft Guidance for Industry on Sterile Drug Products Produced by Aseptic Processing. Pages 52782-52783 [FR Doc. 03-22576] [TXT] [PDF] [PRE-PUB] Comments November 4, 2003
MEETINGS
Docket No. 03N-0361, OC 2003266. Anti-Counterfeit Drug Initiative: Public Meeting. Pages 52772-52775 [FR Doc. 03-22789] [TXT] [PDF] [PRE-PUB] Meeting to be held October 15, 2003 Notice of Intent to attend due October 9, 2003 Summary of Presentation due September 24, 2003
OC 2003259. General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. Pages 52775-52776 [FR Doc. 03-22580] [TXT] [PDF] [PRE-PUB] Meeting October 14, 2003 and October 15, 2003
OC 2003253. Food Biotechnology Subcommittee of the Food Advisory Committee; Notice of Meeting. Page 52775 [FR Doc. 03-22581] [TXT] [PDF] [PRE-PUB] Meeting September 24, 2003
OC 2003252. Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science; Amendment of Notice. Page 52776 [FR Doc. 03-22628] [TXT] [PDF] [PRE-PUB] Meeting September 17, 2003
Table of Contents for Entire Federal Register
Friday, September 5, 2003
(TXT)
(PDF)