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FDA releases a draft guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.[ Price : $8.95]
FDA approves the expanded use of Amarins Vascepas (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to s...[ Price : $8.95]
Federal Register notice: FDA issues a final rule amending requirements for medical device premarket submissions to require a singl...[ Price : $8.95]
Federal Register: FDA makes available a draft guidance entitled FDARA Implementation Guidance for Pediatric Studies of Molecularly...[ Price : $8.95]
Futura Medical says it intends to discuss with FDA a medical device regulatory approval pathway for the placebo arm from an erecti...[ Price : $8.95]
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representati...[ Price : $8.95]
FDA qualifies the first computational modeling tool to be used with a wide range of implantable active medical devices through the...[ Price : $8.95]
FDA releases an FDA-483 with seven observations from an inspection at the Exela Pharma Sciences outsourcing facility.