FDA clears a MagVenture 510(k) for a faster treatment protocol for its Transcranial Magnetic Stimulation and its use in treating depression.
FDA approves Dompe Farmaceuticis Oxervate to treat neurotrophic keratitis, the first for this disease.
FDA warns Chinas Hangzhou Karic Commodities about CGMP violations in its production of finished pharmaceuticals.
Four drug companies recommend changes to an FDA draft guidance on developing drugs to treat major depressive disorder.
Sen. Edward Markey says FDA may have ignored REMS signals of inappropriate prescribing of a specific class of fentanyl products.
FDA warns Japans Kyowa Hakko Bio Co. about repeat CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Federal Register notice: FDA makes available a final guidance entitled Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendatio...
Federal Register notice: FDA makes available a final guidance entitled Quality Attribute Considerations for Chewable Tablets.