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# CBER Sponsor Regulatory Meetings SOPP
- URL: https://www.fdaweb.com/cber-sponsor-regulatory-meetings-sopp-d5161825/
- Published: 2026-09-23T16:00:00.000Z
- Updated: 2026-09-23T16:00:00.000Z
- Author: David McFarland
- Tags: Biologics, Legacy-ID-D5161825, #Import 2026-09-24 19:50

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](https://www.fda.gov/media/84040/download?attachment&ref=fdaweb.com) 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.”