CDRH launches a new Web page entitled Antimicrobial Resistance and Medical Devices.
Federal Register notice: FDA makes available a final guidance entitled Q9(R1) Quality Risk Management.
Federal Register notice: FDA posts a list of 15 information collections that have been recently approved by OMB.
A FibroGen Phase 3 study of its anemia drug roxadustat fails to meet its primary efficacy endpoint.
FDA issues Ajinomoto Bio-Pharma Services a three-item Form FDA-483 after inspecting the firm in January.
A citizen petition from PhRMA and other groups urges FDA to not approve a proposal from Colorados Department of Health Care Policy & Financing that se...
FDA reviewers question the reliability of an actual use study that was submitted to support approval of a Laboratoire HRA Pharma NDA seeking a prescri...
FDA accepts for review a Glaukos NDA for iDose TR (travoprost intraocular implant) for treating open-angle glaucoma or ocular hypertension.
