New research questions FDA’s reliance on and inability to enforce postmarketing requirements
As the FDA has increasingly relied on postmarketing requirements (PMRs) to support its approval decisions, a new study published in the Milbank Quarterly discusses how the FDA’s lack of ability to enforce PMRs reveals an agency “on guard against a set of larger political threats to its mandate.”
The study’s publication follows a recent report from the FDA showing that most of the required PMRs and voluntary postmarketing commitments (PMCs) are progressing on schedule.
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