Four stakeholders update comments on the latest version of an FDA draft guidance on topical ophthalmic products.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...
FDA denies a Boehringer Ingelheim petition asking it to change its interpretation of strength for parenteral solutions under the Biologic Price Compet...
FDA posts a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide.
FDA India director Sarah McMullen says the agency is working to increase drug inspections in India and station additional investigators there.
Viking Therapeutics says its Phase 2 clinical trial of obesity drug VK2735, a dual agonist of glucagon-like peptide 1 and glucose-dependent insulinotr...
