FDA provides update on status of postmarketing reports and commitments

The US Food and Drug Administration (FDA) reports that the majority of sponsors have submitted their postmarketing requirements (PMRs) and postmarketing commitments (PMCs) on time for FY 2022, according to its latest annual report.

The agency announced that “applicants successfully completed (fulfilled) or released most of the PMRs/PMCs for the previous years reported on in the FY 2022 report. The majority of PMRs/PMCs are progressing according to the original schedule. Overall, few PMRs/PMCs are delayed.”

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 to conduct in writing but is not required to do so by statute or regulation. FDA can require application holders to conduct these studies to assess a known serious risk or assess signals of serious risk.

FDA classifies PMRs and PMCs as open or closed, and either on-schedule or off-schedule, if they missed a milestone date in the original schedule. Open PMRs/PMCs are either pending, ongoing, delayed, submitted, or terminated, while closed PMRs/PMCs are either fulfilled or released.

As of 30 September 2022, there were 798 new drug applications (NDAs) and biological license applications (BLAs) with open PMRs and PMCs. Of these, 277 were unique NDA applicants and 109 were unique BLA applicants. Of the 277 NDAs that were required to submit annual status reports (ASRs) in FY 2022, 83% were received on time, 10% were late, and 7% were expected but not received during FY 2022. Of the 109 BLAs that were required to submit ASRS, 82% were submitted on time, 14 % were late, while 4% were expected but not received in FY 2022.

FDA also reports that in FY 2022, 70% of the open PMRs for NDAs and BLAs combined and 78% of the open PMCs for combined NDAs add BLAs, were progressing on schedule.

FDA also provided information on the status of open and off-schedule PMRs: At the end of 30 September 2022, 33% of the open NDA PMRs and 18% of the open BLA PMRs were off schedule. Of the off-schedule NDA and BLA PMRs, 99% were off schedule because they were delayed, and the remaining off-schedule NDA and BLA PMRs were terminated.

For PMCs, FDA reports that 39% of on-schedule NDA PMCs were pending and 40% of open, on-schedule BLA PMCs were ongoing. In addition, 22% of open NDA and BLA PMCs were considered off schedule while the majority of off-schedule NDA and BLA PMCs were delayed from the original schedule milestones.

FDA reports that the majority of closed PMRs were fulfilled, or 64% of NDA PMRs and 89% of BLA PMRs at the end of FY 2022.

Report

FDA provides update on status of postmarketing reports and commitments

Related topics

Recommended content

Welcome to the new RAPS Digital Experience