FDA expected to require manufacturing info in applications

The US FDA is expected to require more manufacturing site information on drug product applications. Edwin Rivera-Martinez, the FDA's chief of the international compliance in CDER’s manufacturing division said 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. Rivera-Martinez also said the agency will double its overseas inspections of facilities for GMP compliance this year from 50 to 100.
FDA News
FDA News