FDA finds most postmarketing requirements, commitments progressing on schedule

Most drug and biological manufacturers met their postmarketing requirements (PMR) and postmarketing commitments (PMC) during fiscal year (FY) 2024, according to a report from the US Food and Drug Administration (FDA).

FDA requires sponsors of approved drug and biological products to conduct a PMR study if there is a known serious risk associated with the product or if the product can treat pediatric populations but is not adequately labeled for children.  Additionally, the FDA may require a PMR to verify the predicted effects of drugs that were approved under the accelerated approval process. A PMR may also be required for products approved based on animal efficacy data due to ethical concerns about human efficacy trials.

A PMC is a postapproval study or clinical trial that the applicant agrees to conduct but is not required by statute or regulation.

FDA categorizes PMRs/PMCs as open (pending, ongoing, delayed, submitted, or terminated) or closed (fulfilled or released), and as on-schedule or off-schedule, depending on whether the applicant has missed a milestone date in the original schedule. Sponsors subject to PMRs/PMCs are required to submit an annual status report (ASR) within 60 days of the product’s original approval or according to an alternate reporting schedule if granted by the agency.

As with the agency’s FY2023 report, FDA finds that most PMRs/PMCs “were progressing on schedule” (RELATED:  Majority of applicants complied with postmarketing requirements, commitments, Regulatory Focus, 2 June 2025).

In FY 2024, 70% (1,147 of 1,636 new drug applications [NDAs] and biologics license applications [BLAs]) of open PMRs and 80% PMCs (307 of 386 NDAs and BLAs) of PMCs were submitted on time.

An average of 299 PMRs were established each year since FY 2018, the report noted. A higher percentage of PMRs set up in earlier years have been fulfilled than in later years. For instance, 35% (112 of 316) of the PMRs established in FY 2018 have been completed, while 24% (75 of 316) have been delayed. In contrast, in FY 2024, 87% (220 of 252) of the PMRs established in FY 2024 are pending, and 6% (16 of 252) are ongoing.

On the PMC front, the report finds an average of 84 PMCs have been established each year since FY 2018. Like the trend observed in PMRs, the report finds that most of the PMCs established in earlier years have either been fulfilled or released. For instance, 69% (69 of 100) of the PMCs established in FY 2018 were fulfilled, while only 1% of those established in FY 2024 have been fulfilled.

The report also addresses how applicants must submit an annual status report (ASR) on the progress of each open PMR/PMC within 60 days of the approval anniversary. In FY 2024, 537 NDAs and 213 BLAs required an ASR due in FY 2024.

Of the 537 NDA ASRs due in FY 2024, 80% (430 of 537) were submitted on time, 8% (45 of 537) were submitted but not on time, and 12% (62 of 537) were expected but not received during FY 2024.  Of the 213 BLA ASRs due, 72% (153 of 213) were received on time, 10% (21 of 213) were not submitted in time, and 18% (39 of 213) were expected but not received during FY 2024.

Report