BULK PHARMACEUTICAL PROCESS VALIDATION "TRANSITION PERIOD" COMING TO AN END, FDA OFFICER TELLS NAPM; DOSAGE FORMS WILL NEED BULK VALIDATION FOR MARKETING
FDA's "transition period" for bulk pharmaceutical process validation will end and the agency "will be looking for [process validation reports] as part of approval for a dosage form," Compliance Officer Maura Slattery told a National Association of Pharmaceutical Manufacturers meeting in New York City March 7.
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