Federal Register Notice: FDA’s Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science will meet 7/20-21 from 8:30 a.m. to 5 p.m. at the CDER Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD. On 7/20, the subcommittee will address the following issues: (1) Receive topic updates for ongoing activities pertaining to manufacturing science and quality by design; and (2) discuss and provide comment on a Current Good Manufacturing Practice (cGMP) risk model being developed at FDA. On 7/21, the subcommittee will address the following issues: (1) Discuss and provide comments on a cGMP and quality system approach for the production of investigational new drugs (INDs) and (2) discuss and provide comments on manufacturing science and risk-based questions for new drug application chemistry, manufacturing and controls (NDA CMC) review process. Contact Hilda Scharen, (301) 827-7001. To view this notice, click here.
