Federal Register Notice: FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology will meet 5/1-2, from 8:30 a.m. to 5 p.m. at the CDER Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD. On 5/1 the committee will: 1) Receive and discuss updates from the 10/18-19/06 Clinical Pharmacology Subcommittee Meeting and the 4/30/07, 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strategies and directions for the Critical Path Initiative; (3) receive an update and discuss revisions to the FDA draft guidance for industry entitled Comparability Protocols — Chemistry, Manufacturing, and Controls Information; (4) discuss current thinking on risk-based approaches to managing post-approval activity.

On 5/2, the committee will: (1) Receive an Office of Generic Drugs (OGD) update on the bioequivalence of highly variable drugs, (2) receive an update on and discuss general strategies within OGD on the bioequivalence of narrow therapeutic index drug products, and (3) discuss and provide comments on alcohol-induced dose dumping. Contact Victoria Ferretti-Aceto, (301) 827-7001. To view this notice, click here.