Postmarket surveillance under FDAMA should be last resort to other controls -- HIMA.
This article was originally published in The Gray Sheet
Executive SummaryPOSTMARKET 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).
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.