FDA says two additional Warning Letters have been issued to Chinese medical device firms as part of its evaluation of defective plastic enteral syring...
FDA publishes a guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies of invest...
Federal Register notice: FDA makes available a final guidance entitled Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy.
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Federal Register notice: FDA extends the comment period on its draft guidance entitled Platform Technology Designation Program for Drug Development....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...
