> ## 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.

# 2 CDER Postmarketing MAPPS Out
- URL: https://www.fdaweb.com/2-cder-postmarketing-mapps-out/
- Published: 2026-04-15T12:00:00.000Z
- Updated: 2026-09-14T13:37:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160988

CDER has issued two Manuals of Policies and Procedures (MAPP) on postmarketing requirements. MAPP 6010.9 Rev. 1, [*Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments*](http://www.fda.gov/media/75065/download?attachment&ref=fdaweb.com), applies to the development of all reportable 506B postmarketing commitments (PMCs) for drugs and licensed biological products regulated by CDER, and the communication of chemistry, manufacturing, and controls PMCs between the Office of Pharmaceutical Quality and the Office of New Drugs. It also applies to 506B postmarketing requirements (PMRs) under the Animal Efficacy Rule or accelerated approval, studies required under the Pediatric Research and Equity Act, and studies or clinical trials required under section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.

The MAPP says all PMRs/PMCs will be communicated using a standardized process described in MAPP 6010.8 and as authorized under relevant PDUFA and BsUFA provisions. All “anticipated” PMRs will be communicated as required by PDUFA 7 and BsUFA 3 and 506B PMCs may be communicated as appropriate.

MAPP 6010.2 Rev. 2, [*Responsibilities for Tracking, Monitoring, and Communicating the Status of Postmarketing Requirements and Commitments*](http://www.fda.gov/media/77460/download?attachment&ref=fdaweb.com), applies to the same PMCs and PMRs as the first MAPP and says that CDER processes PMR/506B PMC-related submissions as they are received, verifies PMR/506B PMC status, communicates to the applicant any omissions and errors in PMR/506B PMC status reporting, and updates the Electronic Records and Knowledge System accordingly.

Under the MAPP, CDER communicates to the applicant missed milestone dates via a Notification of Missed Milestones letter.