Why are Post-Approval Pregnancy Studies Post-Marking Requirements Rather Than Post-Marketing Commitments?
FDA Law Blog
JANUARY 7, 2024
A PMR is a study “that sponsors are required to conduct under one or more statutes or regulations,” whereas a PMC is a study “that a sponsor has agreed to conduct, but that are not required by a statute or regulation” (see FDA Webpage, Postmarketing Requirements and Commitments: Introduction ).
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