FDA posts a draft guidance entitled How to Obtain a Covered Product Authorization for generic drug developers having trouble getting samples for devel...
Federal Register notice: FDA determines that GlaxoSmithKlines prescription-only NIX (permethrin) 1% topical creme rinse was not withdrawn from sale fo...
FDA releases a form FDA-483 with five observations from an inspection at the Cipla drug manufacturing facility in Goa, India.
FDA concurs with six recommendations made by the HHS Inspector General to improve the EUA process for tests in a future pandemic.
FDA approves Fennec Pharmaceuticals Pedmark to treat cisplatin-associated ototoxicity in pediatric patients.
Federal Register notice: FDA announces an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (n...
FDA approves a Guerbet NDA for Elucirem (gadopiclenol), a new macrocyclic gadolinium-based contrast agent for use in contrast-enhanced magnetic resona...
FDA issues contract manufacturer Catalent a 12-item Form FDA-483 over GMP concerns found during a recent inspection at the firms Bloomington, IN facil...
