> ## 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.

# Drug Postmarketing Commitments On Track: FDA
- URL: https://www.fdaweb.com/drug-postmarketing-commitments-on-track-fda/
- Published: 2019-08-06T12:00:00.000Z
- Updated: 2026-09-15T01:42:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144701

The FDA annual report on drug and biologic postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for FY 2018 shows that as of 9/30/18 there were 318 unique applicants with open PMRs/PMCs under 755 unique NDAs and BLAs. In the previous fiscal year, there were 299 unique applicants with open PMRs/PMCs under 866 unique NDAs and BLAs.

The [report](https://www.fda.gov/media/129657/download?ref=fdaweb.com) also shows that 81% of the open PMRs are on schedule. And it shows that 69% of PMR/PMC annual status reports were received on time. For those that were open but not due, 79% for NDA and 86% for BLA PMRs were progressing on schedule, and most open PMCs (76% for NDAs and 84% for BLAs) were also on schedule.

Commenting on the document, FDA acting commissioner **Ned Sharpless** [says](https://www.fda.gov/news-events/fda-brief/fda-brief-fda-issues-annual-report-efforts-hold-industry-accountable-fulfilling-critical-post?ref=fdaweb.com) the report shows that the majority of PMRs and PMCs “were successfully completed or are progressing toward completion according to the original schedule, with very few studies delayed…. We are committed to working with companies on these issues and holding them accountable for completing these important studies on time to ensure that our understanding of a drug’s safety and efficacy keeps pace with its use in all relevant populations once a product is approved.”