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PMA USER FEES COULD PROVIDE "FIX" NOT IN FDA REFORM PROPOSALS, KESSLER SUGGESTS; FDA COMMISSIONER REITERATES OPPOSITION TO THIRD-PARTY PMA REVIEW

This article was originally published in The Gray Sheet

Executive Summary

Charging user fees for FDA review of premarket approval applications as an alternative to current legislative reform proposals was suggested by agency Commissioner David Kessler May 6 at the inaugural meeting of the Massachusetts Medical Device Industry Council (MassMEDIC) in Boston.

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