FDA Sees Better Industry Compliance With Postmarket Requirements

Posted 28 November 2016 | By Michael Mezher 

FDA Sees Better Industry Compliance With Postmarket Requirements

A new report from the US Food and Drug Administration (FDA) reveals improvements made by industry in complying with postmarketing requirements (PMRs) and postmarketing commitments (PMCs) for Fiscal Year (FY) 2015.

In October, FDA released a lengthy and complicated report detailing industry compliance with PMR/PMC reporting requirements for FY2013 and FY2014.


Under federal regulations, companies are required to submit an annual report to FDA for each post-approval study (including clinical safety, efficacy, pharmacology, nonclinical toxicology studies or clinical trials) they are required to conduct or have committed to in writing.

Under the regulations, applicants must submit a report on the progress of the PMR/PMC within 60 days of the anniversary of the product's approval until the PMR/PMC is completed or terminated and FDA determines that the PMR/PMC has been fulfilled or that the PMR/PMC is no longer feasible or would no longer provide useful information.

Similarly, FDA is required publish an annual report detailing the status of PMRs/PMCs.

FY2015 Report

According to the new report, the number of unique new drug application (NDA) and biologics license application (BLA) applicants with open PMRs and PMCs has remained fairly stable, increasing slightly from 257 in FY2014 to 269 in FY2015.

However, compared to the previous two years, the proportion to reports received on time compared to those received late, or not yet received, has increased.

In FY2014, FDA reported that had only received reports within the 60-day window for 60% of NDAs and 69% of BLAs. In FY2015, the agency says those figures rose to 67% and 78%, respectively.

According to FDA, the shift between the two years is due to fewer companies submitting their reports late. In FY2014, 21% of NDAs and 20% of BLAs had late reports, whereas those numbers dropped to 14% and 13% in FY2015.

FDA also says that the share of on-schedule (i.e. not delayed or terminated) reports has increased compared to the previous two years. In FY2015, FDA says that 88% of open NDA PMRs and 91% of open BLA PMRs were on-schedule, compared to 84% and 89% the previous year. However, for PMCs, FDA says there was a decrease in the percentage of on-schedule programs for NDAs (69% in FY2015 versus 77% in FY2014), and an increase in the percentage of on-schedule programs for BLAs (78% in FY2015 versus 74% in FY2014).

Similar to the previous year, FDA says that the vast majority of PMRs/PMCs that were not progressing as planned were delayed rather than terminated.


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