Federal Register Notice: FDA’s Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science will meet 4/18-19, from 8:30 a.m. to 5 p.m. at CDER’s Advisory Committee Conference Room, Rm 1066, 5630 Fishers Lane, Rockville, MD.

On 4/18 the subcommittee will: (1) Receive topic updates for ongoing activities pertaining to the International Conference on Harmonization (ICH) Q8, Q9, Q10, and future ICH quality topics; and (2) discuss and provide comments on modernized Current Good Manufacturing Practice approaches to process validation that encourage continuous improvement over the product life-cycle. On 4/19, the subcommittee will: (1) Discuss and provide comments on the agency's new approaches to Chemistry, Manufacturing, and Control (CMC) guidance development, as illustrated by the comparability protocol guidance; (2) discuss and provide comments on the CMC Pilot Program; and (3) receive an update on the Cooperative Research and Development Agreement (CRADA) with Conformia Software, Inc., to obtain information on factors influencing pharmaceutical development. Contact Mimi T. Phan, (301) 827-7001. To view this notice, click here.