Medtronic Neurology recalls its Duet External Drainage and Monitoring System, which is used to drain cerebrospinal fluid (CSF) to reduce intracranial ...
An HHS-funded RAND study finds that many new drugs are available in the U.S. before launching in other countries.
Federal Register notice: FDA issues an order to reduce a five-year debarment against former Indivior global medical director Timothy Baxter.
A detailed FDLI analysis looks at how expected Supreme Court changes to the Chevron federal agency deference principle will likely affect FDA and regu...
FDA accepts for priority review an Applied Therapeutics NDA for AT-007 (govorestat) for treating classic Galactosemia.
FDA warns Amman, Jordan-based Amman Pharmaceutical Industries about CGMP violations in its production of drugs as a contract manufacturer.
FDA fails to locate the UK-based manufacturer of filthy eye drops, LightEyez, accused of manufacturing and distributing unapproved and adulterated ove...
FDA warns Mamaroneck, NY-based Delsam Pharma, and Lakewood, NJ-based EzriCare about distributing adulterated and misbranded ophthalmic products obtain...
