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Pharmaceuticals / Regulatory Affairs / Postmarket Safety

FDA: Most Sponsors’ PMRs on Time, But Reporting Lags Behind

Dec. 13, 2017
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Most drugmakers are fulfilling their postmarketing study commitments, but many are not meeting their deadlines for annual status reports, the FDA said.

One-third of the status reports were either received late or not at all, according to the agency’s last annual accounting. Companies are required to provide an update on the progress of their PMRs within 60 days of the anniversary of the FDA’s approval of the drug.

Of the 1,323 PMRs open by the end of fiscal 2016, 84 percent related to NDAs and 91 percent of BLAs were considered on-schedule. Nearly half of open NDA and BLA PMRs were pending — 49 and 45 percent, respectively — including studies or clinical trials that have not yet been initiated.

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