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Hyman, Phelps & McNamara senior medical device regulation expert Lisa Baumhardt critiques a recent FDA draft guidance on the Q-Sub...[ Price : $8.95]
The CDER Office of Translational Sciences 2023 annual report lists achievements in seven program areas.[ Price : $8.95]
FDA posts a final guidance entitled Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues.[ Price : $8.95]
Sens. Durbin and Blumenthal introduce legislation to authorize FDA to ban the marketing of tianeptine, currently being sold as a d...[ Price : $8.95]
Abbotts Thoratec unit recalls its HeartMate 3 and left ventricular assist system implant kit due to the potential for a leak.[ Price : $8.95]
CDRH qualifies the Apple Watchs Atrial Fibrillation History Feature as a medical device development tool for use as a biomarker te...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled New Animal Drugs for Investigational U...[ Price : $8.95]
Five stakeholders generally praise FDA efforts in a draft guidance on key information and facilitating understanding in informed c...