Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances on the design of bioequivalence studies...
FDA grants Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in some diabetes patients.
FDA clears a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System for use in implanting surgical reflectors in abnormal breast tissu...
FDA makes available a final guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.
Federal Register notice: FDA announces that its Office of Digital Transformation has modified its organizational structure.
FDA publishes for public comment 29 new and 33 revised product-specific guidances.
FDA commissioner Robert Califf says the recent worldwide reporting of a call to end Covid vaccines by the Florida surgeon general is an example of the...
Sens. Durbin and Braun call on FDA to update its prescription ad guidance to reflect the explosion in social media and to prioritize protecting childr...
