Following adverse events, including one death. and incorrect results, FDA publishes a draft guidance on biotin testing in in vitro diagnostic tests.
FDA selects four companies to participate in a drug supply chain blockchain pilot project.
Federal Register notice: FDA announces a 7/25 Arthritis Advisory Committee meeting to discuss a Boehringer Ingelheim supplemental NDA for Ofev (ninted...
Federal Register notice: FDA makes available a draft guidance entitled Mouse Embryo Assay for Assisted Reproduction Technology Devices.
A federal judge orders FDA to return $19 million worth of the dietary supplement DMAA to Hi-Tech Pharmaceuticals.
Attorney James Beck says a recent International Trade Commission ruling against Amarin Pharmaceuticals upholds the Buckman case principle that private...
Certara says its Simcyp physiologically-based pharmacokinetic modeling and simulation technology was used to demonstrate bioequivalence in an undisclo...
FDA clears a Materialise 510(k) for its Mimics Enlight cardiovascular planning software suite.