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Federal Register: FDA makes available a draft guidance entitled FDARA Implementation Guidance for Pediatric Studies of Molecularly...[ Price : $8.95]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.[ Price : $8.95]
A CDER Webinar explains updates to forms FDA-3542a and 3542 and instructs participants on how to complete the forms.[ Price : $8.95]
FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology dru...[ Price : $8.95]
The Senate confirms Stephen Hahn as the next FDA commissioner on a floor vote of 72-18.