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 releases the form FDA-483 with seven observations from an inspection at the Englewood, CO-based Leiters Health outsourcing facility.
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Federal Register notice: FDA extends the comment period on its draft guidance entitled Platform Technology Designation Program for Drug Development....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.
