Federal Register notice: FDA establishes a public docket to assist with developing a policy or guidance document on assessing pH-dependent drug-drug i...
Avadel asks FDA to impose restrictions on any NDAs for desmopressin drug products to treat nocturia due to nocturnal polyuria.
FDA releases its latest batch of Warning Letters that includes Emmett F. Branigan, Cerno Pharmaceuticals and Nox Bellcow Cosmetics.
Abbott recalls its HeartMate 3 Left Ventricular Assist System due to a malfunction in the devices outflow graft assembly that may cause the outflow gr...
A CDRH Webinar updates stakeholders on progress toward implementation of a digital health software precertification pilot program by the end of this y...
FDA issues a draft guidance with recommendations for designing and conducting maximal usage tests for topical active ingredients being considered for ...
FDA clears a Providence Medical Technology 510(k) for its DTrax Spinal System, indicated for use in posterior cervical fusion in patients with cervica...
Federal Register notice: FDA makes available a guidance entitled Bioanalytical Method Validation.