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Panel Meeting Canceled

04/05/2007

Federal Register Notice: FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology scheduled for 5/1-2 is canceled. The committee was slated to (1) Receive and discuss updates from the 10/18-19 Clinical Pharmacology Subcommittee Meeting and the April 30, 2007, Manufacturing Subcommittee Meeting; (2) receive an update, discuss and make comments on current strategies and directions for the Critical Path Initiative; (3) receive an update and discuss revisions to the FDA draft guidance for industry entitled “Comparability Protocols — Chemistry, Manufacturing, and Controls Information;” and (4) discuss current thinking on risk-based approaches to managing post-approval activity. On 5/2 the committee was scheduled to (1) Receive an update from the Office of Generic Drugs (OGD) on the bioequivalence of highly variable drugs, (2) receive an update on and discuss general strategies within the OGD pertaining to the bioequivalence of narrow therapeutic index drug products, and (3) discuss and provide comments on the topic of alcohol-induced dose dumping. . For further information, contact Victoria Ferretti-Aceto, (301) 827-7001. To view this notice, click here.

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