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FIRMS REQUESTING PRE-SUBMISSION MEETINGS SPECIFIED IN HOUSE FDA REFORM BILL MUST PROVIDE DETAILED PROTOCOLS; CDRH PREPARING FOR IMPLEMENTATION OF LEGISLATION

This article was originally published in The Gray Sheet

Executive Summary

Sponsors of premarket approval applications seeking a pre-submission meeting to gain feedback on clinical trial protocols must provide the agency with a detailed outline of proposed studies and background on company attendees at the meeting, according to the House Commerce Committee's Oct. 6 report on the stand-alone FDA device reform bill (HR 1710).

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