IMPLEMENTATION OF FDA REFORM LAW's DISPUTE RESOLUTION PROVISION SPURRED BY PENDING PETITIONS FOR PMA RECONSIDERATION CDRH DIRECTOR BURLINGTON SAYS
This article was originally published in The Gray Sheet
Citizen's petitions seeking reevaluation of FDA decisions on several premarket approval applications are motivating the agency to speed implementation of the dispute resolution provision in the FDA Modernization Act of 1997 (FDAMA), signed into law on Nov. 21.
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