CBER Sponsor Regulatory Meetings SOPP

CBER has issued a Standard Operating Policy and Procedure (SOPP) as a guide for Center staff in scheduling and conducting regulatory meetings between individuals in the Center and representatives of regulated companies and/or individual sponsor-investigators to address issues relating to product development. The SOPP applies to meetings for INDs, NDAs, ANDAs, BLAs, and their respective pre-submissions, amendments, and supplements.

FDA says meetings with industry and sponsor-investigators “are a forum for the agency to provide guidance to representatives of the regulated industry … and/or individual sponsor-investigators during product development and facility design, and to facilitate their compliance with the regulations governing development and post-approval marketing of products. While meetings are usually requested by sponsors or applicants or individual sponsor-investigators, CBER will occasionally suggest that a meeting be scheduled.”