Federal Register Notice: FDA’s Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science will meet 11/3, from 8 a.m. to 5:30 p.m., and on 11/4, from 8 a.m. to 1:30 p.m. at the CDER Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD. On 11/3, the subcommittee will: (1) Receive topic updates for ongoing FDA activities previously presented to the subcommittee; (2) discuss and provide comments on the evidence for updating labels of approved drugs to include integrating pharmacogenetic, pharmacokinetic, and prognostic biomarkers for the purpose of optimizing therapeutic response and reducing risks of toxicity; and (3) discuss and provide comments on metabolism- and transporter-based drug-drug interactions included as recommendations in a draft guidance for industry being prepared by FDA. On 11/4, the subcommittee will discuss and provide comments on a new critical path project related to general aspects of biomarker transition to surrogate endpoints, with a focus on planning and process, rather than on specific biomarkers or surrogate endpoints. Contact Hilda Scharen, (301) 827-7001. To view this notice, click here.
