Federal Register notice: FDA makes available a final guidance entitled Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Esta...
FDA grants orphan drug designation to an investigational Menarini drug to treat relapsed/refractory acute myeloid leukemia.
Federal Register notice: FDA makes available a draft guidance entitled Content of Premarket Submissions for Device Software Functions.
FDA says all manufacturers and labelers of isoxsuprine HCl products have agreed to cease distribution of them.
FDA launches a video to help patients keep their medical devices safe from cybersecurity attacks.
FDA releases an FDA-483 with three observations from an inspection at the Atlas Pharmaceuticals outsourcing facility in Phoenix, AZ.
FDA clears a Flume Catheter Co. 510(k) for its Flume urinary balloon catheter.
FDA acting commissioner Janet Woodcock testifies before Congress about an agency priority to increase the availability of over-the-counter Covid-19 ho...