Federal Register notice: FDA makes available a draft guidance entitled Mouse Embryo Assay for Assisted Reproduction Technology Devices.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.
FDA warns Indias Glint Cosmetics about CGMP and other violations in its manufacturing of finished pharmaceuticals.
An FDA safety alert warns about infections with multi-drug resistant organisms after patients received investigational fecal microbiota for transplant...
FDA approves an Amgen BLA for Kanjinti (trastuzumab-anns), the fifth biosimilar copy of Roches Herceptin (trastuzumab).