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Stakeholders suggest improvements to an FDA draft guidance on using real-world evidence in medical device regulatory decisions.[ Price : $8.95]
FDA says Viracor-IBT Laboratories is selling unapproved Zika tests.[ Price : $8.95]
Stakeholders air concerns about an FDA draft guidance on UDI label components.[ Price : $8.95]
Two Harvard Medical School professors question the process FDA used to approve a new Duchenne muscular dystrophy drug.[ Price : $8.95]
Fish & Richardson attorneys review two amicus briefs urging the Supreme Court to hear Apotex biologics law appeal against Amgen an...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a planned direct-to-consumer (DTC) advertising study that has been submitted to OMB...[ Price : $8.95]
Federal Register Notice: FDA announces a 12/5 public workshop on The Role of Hospitals in Modernizing Evidence Generation for Devi...[ Price : $8.95]
FDA warns the Czech Republics Interpharm about CGMP deviations and violations in its production of active pharmaceutical ingredien...