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.
CBER director Peter Marks says he expects 2024 to be a big year for gene therapy approvals as several Center initiatives take hold to advance product ...
Four stakeholders update comments on the latest version of an FDA draft guidance on topical ophthalmic products.
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...
