FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Gottlieb Highlights FDA’s Efforts to Hold Sponsors Accountable for Post-Marketing Studies

Nov. 28, 2018
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FDA Commissioner Scott Gottlieb said the agency is committed to ensuring “timely completion” of post-marketing studies by drug sponsors in a Friday statement about the agency’s latest report on the status of reviews.

Gottlieb highlighted that CDER has nearly wiped out the backlog of safety-related postmarketing requirements (PMRs) and postmarketing commitments (PMCs) still in need of review. The center has taken care of 1,468 PMRs and PMCs that were awaiting agency evaluation, leaving only 85 to go, he said. Additionally, CBER completed 71 of 83 backlogged PMRs and PMCs.

The agency may require PMRs to assess serious risks related to a drug’s use, or to identify unexpected serious risks that data suggest could arise. PMCs are commitments made by drugmakers to conduct post-approval studies to gather more information — such as a drug’s efficacy in a patient subpopulation.

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