> ## 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 Postmarket Requirement/Commitment SOPP
- URL: https://www.fdaweb.com/cber-postmarket-requirement-commitment-sopp/
- Published: 2024-02-20T12:00:00.000Z
- Updated: 2026-09-14T14:23:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156388

CBER has issued a standard operating policy and procedure (SOPP), *Postmarketing Requirement/Commitment Related Submissions — Administrative Handling, Review, and CBER Reporting*, that applies to all postmarketing requirements (PMRs) and commitments (PMCs) for licensed biologics and drugs approved under an NDA regulated by CBER. The SOPP says that CBER will:

- accurately track and manage PMR- and PMC-related submissions to ensure closure of the PMR or PMC; and
- review PMR- and PMC-related submissions according to specified timeframes.