Majority of Open PMRs and PMCs Progressing on Schedule, FDA Report Shows

Regulatory NewsRegulatory News
| 16 November 2018 | By Zachary Brennan 

The majority of the open postmarket requirements (PMRs) and commitments (PMCs) in the US Food and Drug Administration’s (FDA) database continues to progress on schedule, according to data from the latest report released Friday.


A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct following approval, while a PMC is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that is not required by statute or regulation. PMRs and PMCs can be issued upon approval of a drug or biologic, or following approval, if warranted.


The latest data show that the vast majority of PMRs and PMCs have been closed, meaning the requirement has been fulfilled or released, and if they were open, they were usually progressing on schedule. In fact, 81% of open PMRs and 76% of open PMCs are progressing on schedule, the report said.

Of those that are open, nearly half of the new drug application (NDA) and biologics license application (BLA) PMRs were pending, with Pediatric Research Equity Act PMRs and Food and Drug Administration Amendments Act PMRs comprising 50% (285/567) and 43% (242/567) of pending PMRs, respectively.

Of the open but off-schedule NDA PMRs, 97% were off schedule because they were delayed, while the remaining 3% were terminated. And all the off-schedule BLA PMRs were delayed.

Of the closed requirements, the majority of closed PMRs were fulfilled (56% of NDA PMRs and 70% of BLA PMRs) at the end of FY2017. Only a slight majority of closed PMCs were fulfilled at the end of FY 2017, and 48% of the NDA closed PMCs were released – meaning either they were no longer feasible or the drug was withdrawn.

The report also discusses how applicants must submit an annual status report (ASR) on the progress of each open PMR/PMC within 60 days of the anniversary date of approval or an alternate date granted by FDA. In FY2017, there were 782 NDAs and BLAs with an ASR due. Of the 629 NDA ASRs due, 68% were received on time, 13% were received not on time and 19% were not received. Of the 153 BLA ASRs due, 73% were received on time, 15% were received not on time and 12% were not received.

While noting that FDA will soon publish a framework on real world evidence to help evaluate its potential use to help support the approval of a new indication or to satisfy post-approval study requirements, Commissioner Scott Gottlieb said: “The results from completed post-market studies provide additional information that can lead to safety labeling changes, support expanded use of a drug, or alleviate concerns about a potential drug risk. FDA is always looking at opportunities to facilitate the conduct and completion of these studies so as to ensure that patients and providers have the most complete data about a drug to inform their treatment decisions.”


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