Federal Register notice: FDA makes available a final guidance entitled Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy.
FDA says a 4/1 Philips Respironics recall revising the use instructions for its OmniLab Advanced+ ventilator is Class 1.
FDA clears a Subtle Medical 510(k) for its SubtleSYNTH, which uses deep learning to generate synthetic Short Tau Inversion Recovery images from alread...
Baxter International recalls (Class 1) certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to report...
Federal Register notice: FDA extends the comment period on its draft guidance entitled Platform Technology Designation Program for Drug Development....
CDER director Patrizia Cavazzoni and CBER director Peter Marks say they are co-leading a new FDA Rare Disease Innovation Hub.
FDA publishes a guidance with its compliance policy about blood establishments failing to comply with some donor eligibility requirements.
Endo recalls (Class 1) one lot of clonazepam orally disintegrating tablets 0.25 mg due to mislabeling on the cartons of some packs that shows the wron...
