A revised safety update on Abiomed's Impella RP System emphasizes proper patient selection after interim post-approval study results indicated a lower...
FDA posts a draft guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Consideratio...
Former FDA commissioner Scott Gottlieb calls for new ways to look at drug pricing to ensure that all who need access to innovative therapies can have ...
An FDA inspection of Cadila Healthcares Gujarat, India manufacturing facility leads to a 23-page Form 483 that cites significant GMP violations.
Federal Register notice: FDA submits to OMB an information collection extension for Exports: Notification and Recordkeeping Requirements 21 CFR 1.101...
A Kaiser Health News report examines Medtronics alternative summary reporting exemption that allowed thousands of adverse events associated with the c...
FDA approves a Stryker PMA for the Neuroform Atlas Stent System, an aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms in conjun...
FDA announces it has modified organizational structures in the Office of the Commissioner, headquarters organizations, and product Centers.