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FDA Application

Federal Register
Thursday January 15, 2009

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FDA Federal Register Documents

PROPOSED RULES

Docket No. FDA-2000-P-0126 (formerly Docket No. 2000P-0685), CFSAN 20075.  Milk and Cream Products and Yogurt Products; Proposal to Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend the Standard for Yogurt.  Pages  2443-2460 [FR Doc. E9-736]  [TXT] [PDF] [PRE-PUB]

NOTICES-FINAL GUIDANCES

Docket No. FDA-2007-D-0202 (formerly Docket No. 2007D–0106), OC 2008150.  Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Adverse Event Reporting--Improving Human Subject Protection; Availability.  Pages  2599-2600 [FR Doc. E9-683]  [TXT] [PDF] [PRE-PUB]

The Guidance

Docket No. FDA-2004-D-0043, CFSAN 200843.  Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association; Availability.  Pages  2600-2601 [FR Doc. E9-785]  [TXT] [PDF] [PRE-PUB]

The Guidance

NOTICES

Docket No. FDA-2008-N-0543, OC 20094.  Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.  Pages  2598-2599 [FR Doc. E9-782]  [TXT] [PDF] [PRE-PUB]

Docket No. FDA-2008-N-0656, CDER 20082.  Secure Supply Chain Pilot Program; Notice of Pilot Program.  Pages  2605-2608 [FR Doc. E9-791]  [TXT] [PDF] [PRE-PUB] Comments due March 16, 2009

MEETINGS

Docket No. FDA-2008-N-0661, CDRH 200866.  Unique Device Identification System; Public Workshop; Request for Comments.  Pages  2601-2605 [FR Doc. E9-784]  [TXT] [PDF] [PRE-PUB] Public workshop on February 12, 2009 Comments due February 27, 2009

FINAL RULES

Docket No. FDA-2004-N-0117 (formerly Docket No. 2004N–0242), OC 2007304.  Institutional Review Boards; Registration Requirements.  Pages  2358-2369 [FR Doc. E9-682]  [TXT] [PDF] [PRE-PUB] Effective Date July 14, 2009 Revisions to registrations due September 14, 2009


Table of Contents for Entire Federal Register
Thursday, January 15, 2009 (TXT)  (PDF)

 
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