The House Committee on Oversight and Accountability calls on FDA to provide extensive information on its response to a growing number of what the comm...
FDA accepts for review a Supernus Pharmaceuticals NDA resubmission for its apomorphine infusion device (SPN-830) for the continuous treatment of Parki...
Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.
FDA clears an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform pulse and respiratory rate.
The Harvard Drug Group recalls all lots of polyvinyl alcohol, 1.4% lubricating eye drops and lubricating tears eye drops (dextran/hypromellose, 0.1%/0...
A BMJ investigation looks at the case of two former FDA vaccine officials who now work for Moderna.
Eli Lilly says that an FDA review decision for its experimental Alzheimers drug donanemab has been pushed back to the first quarter of 2024.
FDA posts a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.
