Federal Register
Thursday October 1, 2009

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FDA Federal Register Documents

PROPOSED RULES

Docket No. FDA-2008-N-0424, OC 200667.  Postmarketing Safety Reporting for Combination Products.  Pages  50744-50758 [FR Doc. E9-23519]  [OFR PUB]

NOTICES

Docket No. FDA-2009-D-0461, CDER 200911.  Draft Guidance for Industry on Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications; Availability.  Pages  50801-50802 [FR Doc. E9-23616]  [OFR PUB] Comments due December 30, 2009

Docket No. FDA-2009-E-0017 & FDA-2009-E-0019, CDER 200945.  Determination of Regulatory Review Period for Purposes of Patent Extension; CLEVIPREX.  Page  50801 [FR Doc. E9-23650]  [OFR PUB] Comments due November 30, 2009 Petition diligence due March 30, 2010

Docket No. FDA-2008-N-0281, CDER 200962.  Pilot Program to Evaluate Proposed Proprietary Name Submissions; Procedures to Register for Participation and Submit Data.  Pages  50806-50809 [FR Doc. E9-23620]  [OFR PUB]

Docket No. FDA-2009-N-0294, OC 2009621.  Regulation of Tobacco Products; Extension of Comment Period (Notice; extension of comment period).  Page  50810 [FR Doc. E9-23607]  [OFR PUB] Comments due December 28, 2009

MEETINGS

Docket No. FDA-2009-N-0664, OC 2009250.  National Mammography Quality Assurance Advisory Committee; Notice of Meeting.  Page  50803 [FR Doc. E9-23621]  [OFR PUB] Meeting on November 2, 2009

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Table of Contents for Entire Federal Register
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