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...
CDER director Patrizia Cavazzoni says the 2023 Drug Safety Priorities report focuses on the nations drug overdose crisis.
Pharmaceutical Research and Manufacturers of America asks FDA to take some specific follow-up steps to its virtual meeting on advancing the developmen...
