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FDA reform law's PMA manufacturing change exemption to eliminate 20 supplements annually .

This article was originally published in The Gray Sheet

Executive Summary

FDA EXPECTING 20 FEWER PMA SUPPLEMENT SUBMISSIONS ANNUALLY as a result of the FDA Modernization Act (FDAMA) provision exempting minor manufacturing changes from premarket review. "It looks like about 5% of the PMA supplements that we currently receive" will be affected by the provision, Office of Device Evaluation Director Susan Alpert said at a Dec. 3 Food & Drug Law Institute videoconference on FDAMA implementation plans by the Center for Devices and Radiological Health.



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