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Proposed GMP design controls to be discussed at advisory committee meeting in June.

This article was originally published in The Gray Sheet

Executive Summary

PROPOSED DEVICE GMP DESIGN CONTROLS' EFFECT ON R&D will be examined at an upcoming meeting of FDA's Good Manufacturing Practices Advisory Committee, according to agency staffers. The agenda for the meeting, tentatively scheduled for June, likely will include discussion about whether design control provisions in the proposed revisions to GMP regulations would create an obstacle to manufacturers' R&D efforts.



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