FDA medical reviewers tell members of the Cardiovascular and Renal Drugs Advisory Committee there are safety concerns with GlaxoSmithKlines anemia dru...
Federal Register notice: FDA makes available a draft guidance entitled In Vitro Release Test Studies for Topical Products Submitted in ANDAs.
FDA warns West Columbia, SC-based Nephron SC about CGMP and other violations at its drug manufacturing facility.
FDA says it is postponing a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that was scheduled to review and vote on an Ipsen Biop...
FDA warns Chatsworth, CA-based Advanced Cosmetic Research Laboratories about CGMP violations and marketing of misbranded unapproved new drugs.
FDA releases the form FDA-483 with six observations from an inspection at Indias Jubilant Generics.
FDA clears a NeuroOne Medical Technologies 510(k) to market its Evo sEEG Electrode technology for temporary (less than 30 days) use for the recording,...
FDA approves AstraZenecas Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for treating adult patients with unresectable liver cancer.
