FDA warns Australias Antaria Pty. Ltd. about CGMP deviations in its production of active pharmaceutical ingredients.
A Congressional Research Service paper points to possible legislation Congress may want to consider to clarify how FDA is to use confidential informat...
A KFF Health News report carried online by NBC says 10 members of an FDA advisory committee evaluating an Abbott cardiac device had received money fro...
CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in communications to healthcare providers may help them for...
An FDA inspection last month at Alkem Laboratories India manufacturing facility leads to a 10-observation Form FDA-483.
A federal court approves an FDA-brokered consent decree against Philips Respironics over its defective breathing devices.
FDA approves ViiV Healthcares Dovato (dolutegravir/lamivudine) for treating HIV-1 infection in adolescents with no antiretroviral treatment history or...
FDA accepts for review a Stealth BioTherapeutics NDA for elamipretide for treating Barth syndrome.
