Final Rule Is Expected on Manufacturing Site Data in Drug Applications

The FDA is working on a direct final rule to require more manufacturing site information on drug product applications. The rule is designed to cut down on unneeded FDA inspections and erroneous information about manufacturing sites by requiring sponsors to list establishments and locations involved in manufacturing drug products, Edwin Rivera-Martinez, chief of the international compliance branch in CDER’s division of manufacturing and compliance, said last week at the 14th Annual GMP by the Sea conference in Cambridge, Md. No date for issuing the rule has been set.
Drug Industry Daily