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PMAs BASED ON "LEAST BURDENSOME" STUDIES MUST BE JUSTIFIED BY SPONSORS IN PRE-SUBMISSION MEETINGS, FDA's BURLINGTON SAYS; PROVISION TAKES EFFECT FEB. 20

This article was originally published in The Gray Sheet

Executive Summary

Premarket approval application sponsors must prove in pre-submission meetings with FDA why less burdensome trials are an acceptable alternative to "the highest quality scientific approach," FDA Center for Devices and Radiological Health Director Bruce Burlington said at a Dec. 3 videoconference sponsored by the Food & Drug Law Institute. Burlington's comment came during a discussion of the FDA Modernization Act's provision on pre-submission meetings.
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