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...
FDA medical reviewers ask the Oncologic Drugs Advisory Committee whether the CodeBreak 200 post-marketing trial of Amgens Lumakras can be considered a...
AdvaMedDx says it has many questions about an immediately effective FDA guidance on a pilot of oncologic drugs that use in vitro tests.
