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Postmarket surveillance under FDAMA should be last resort to other controls -- HIMA.

This article was originally published in The Gray Sheet

Executive Summary

POSTMARKET SURVEILLANCE SHOULD BE LAST RESORT IN FDA's "EARLY WARNING" SYSTEM, the Health Industry Manufacturers Association maintained at a Jan. 15 FDA/industry public meeting in Gaithersburg, Maryland on how to implement revisions to the agency's tracking and postmarket surveillance (PMS) programs mandated by the FDA Modernization Act (FDAMA).

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