Sens. Durbin and Blumenthal introduce legislation to authorize FDA to ban the marketing of tianeptine, currently being sold as a dietary supplement.
Abbotts Thoratec unit recalls its HeartMate 3 and left ventricular assist system implant kit due to the potential for a leak.
CDRH qualifies the Apple Watchs Atrial Fibrillation History Feature as a medical device development tool for use as a biomarker test to help evaluate ...
Federal Register notice: FDA seeks comments on an information collection extension entitled New Animal Drugs for Investigational Use 21 CFR 511....
Five stakeholders generally praise FDA efforts in a draft guidance on key information and facilitating understanding in informed consent.
CBER director Peter Marks and Brown University medical school professor Eli Adashi say it appears that decentralized clinical trials are a paradigm wh...
A National Mucopolysaccharidoses Society commentary urges FDA to use accelerated approval for promising treatments for rare diseases.
Doctors for America calls on FDA to finalize a guidance on collecting race and ethnicity data in clinical trials and clinical studies.
