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Federal Register notice: FDA makes available a final guidance entitled Q9(R1) Quality Risk Management.[ Price : $8.95]
Federal Register notice: FDA posts a list of 15 information collections that have been recently approved by OMB.[ Price : $8.95]
A FibroGen Phase 3 study of its anemia drug roxadustat fails to meet its primary efficacy endpoint.[ Price : $8.95]
FDA issues Ajinomoto Bio-Pharma Services a three-item Form FDA-483 after inspecting the firm in January.[ Price : $8.95]
A citizen petition from PhRMA and other groups urges FDA to not approve a proposal from Colorados Department of Health Care Policy...[ Price : $8.95]
FDA reviewers question the reliability of an actual use study that was submitted to support approval of a Laboratoire HRA Pharma N...[ Price : $8.95]
FDA accepts for review a Glaukos NDA for iDose TR (travoprost intraocular implant) for treating open-angle glaucoma or ocular hype...[ Price : $8.95]
Federal Register notice: FDA determines that Bayers Levitra (vardenafil HCl) oral tablets (5mg, 10mg and 20mg) were not withdrawn ...