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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