Federal Register notice: FDA determines that Janssen Pharmaceuticals Ultram (tramadol hydrochloride) tablets, 50 mg, was not withdrawn from sale for s...
Moderna says it will start a Phase 3 trial of its investigational mRNA-1083 combination flu/Covid vaccine later this year.
Federal Register notice: FDA proposes to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal...
FDA warns Irving, TX-based Signature Biologics that it is illegally marketing its human umbilical cord product that is manufactured with CGMP deviatio...
FDA warns Fresenius Kabi about CGMP deviations in its Fenwal International unit in Maricao, Puerto Rico.
KVK-Tech recalls one lot of betaxolol tablets as a precautionary measure after a single oxycodone HCl tablet was found on the packaging line during th...
Federal Register notice: FDA announces an 11/16 Oncologic Drugs Advisory Committee meeting to hear an update on the agencys accelerated approval progr...
In a wide-ranging TV interview during a visit to India, FDA commissioner Robert Califf says the agency will be increasing both announced and unannounc...
