> ## 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.

# PMRs and PMCs Generally on Schedule: FDA Report
- URL: https://www.fdaweb.com/pmrs-and-pmcs-generally-on-schedule-fda-report/
- Published: 2024-04-23T12:00:00.000Z
- Updated: 2026-09-14T14:28:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156833

FDA says that applicants completed or released most of the postmarketing reports/postmarketing commitments (PMRs/PMCs) for the previous years reported on in the agency’s FY 2022 [report](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvbWVkaWEvMTc3OTg4L2Rvd25sb2FkP2F0dGFjaG1lbnQ9JnV0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSIsImJ1bGxldGluX2lkIjoiMjAyNDA0MjMuOTM3NjkxNjEifQ.AA0M1-00df9olRn2slJKTRctnrTjqN9lXd9d1gjrCRo/s/1255931999/br/241222987573-l?ref=fdaweb.com) on PMR/PMC status. The majority of PMRs/PMCs are progressing according to the original schedule, it says, and overall few PMRs/PMCs are delayed.

The report shows that as of 9/30/2022, there were 386 unique applicants with open PMRs/PMCs under 798 unique NDAs and BLAs.

It also shows that as of 9/30/2022 there were 1,126 (70%) NDAs and BLAs with open PMRs on schedule and 476 (30%) off schedule. The comparable figures for PMCs were 283 (78%) on schedule and 81 (22%) off schedule.

Applicants are required to submit an annual status report on the progress of each open PMR/PMC within 60 days of the anniversary date of U.S. approval of the original application. The report shows there were 547 NDAs and 199 BLAs with an annual report due in FY 2022\. Of the NDAs, 83% were received on time, 10% were received but not on time, and 7% were expected but not received during the fiscal year. For the BLAs, 82% were received on time, 14% were received but not on time, and 4% were expected but not received.