Hyman, Phelps & McNamara senior medical device regulation expert Lisa Baumhardt critiques a recent FDA draft guidance on the Q-Submission program.
The CDER Office of Translational Sciences 2023 annual report lists achievements in seven program areas.
FDA posts a final guidance entitled Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues.
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Five stakeholders generally praise FDA efforts in a draft guidance on key information and facilitating understanding in informed consent.
