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Final Rule Is Expected on Manufacturing Site Data in Drug Applications

August 28, 2009

Final Rule Is Expected onward Manufacturing Site Data in Drug Applications
The FDA is in operation on a direct final govern to require more manufacturing site information on drug product applications. The guide is designed to cut down on unneeded FDA inspections and erroneous information round manufacturing sites by requiring sponsors to list establishments and locations involved in manufacturing drug products, Edwin Rivera-Martinez, chief of the between nations agreement member in CDER’s division of manufacturing and compliance, said greatest week at the 14th Annual GMP by the Sea conference in Cambridge, Md. No date for issuing the authority has been set.

Written by Samanta · Filed Under FDA News