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FDA REFORM PROVISION MANDATING STRICT ADHERENCE TO 180-DAY PMA REVIEW TIME FRAME WILL LEAD TO MORE RIGOROUS FILING REVIEWS -- ODE's RICHTER

This article was originally published in The Gray Sheet

Executive Summary

FDA likely will raise the standard for premarket approval application filing decisions as a result of the provision in pending FDA reform legislation ordering the agency adhere to the statutory 180-day PMA review time frame, Kimber Richter, Deputy Director for Clinical and Review Policy in FDA's Office of Device Evaluation, indicated at the Oct. 21 Association of Medical Diagnostics Manufacturers annual meeting in Rockville, Maryland.

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