> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CBER Regulatory Meeting SOPP
- URL: https://www.fdaweb.com/cber-regulatory-meeting-sopp/
- Published: 2019-11-06T12:00:00.000Z
- Updated: 2026-09-14T15:52:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145429

CBER has issued a Standard Operating Policy and Procedure on scheduling and conducting regulatory meetings between individuals in the Center and industry representatives, including sponsors/applicants of user fee related products, and/or individual sponsor-investigators to address issues relating to product development. The [document](https://www.fda.gov/media/84040/download?ref=fdaweb.com) applies to meetings for INDs, ANDAs, BLAs, and their respective pre-submissions, amendments, and supplements. It applies to products covered by BsUFA, GDUFA, and PDUFA, and does not apply to device submissions covered by MDUFA.