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Federal Register notice: FDA makes available a draft guidance entitled Clinical Decision Support Software.[ Price : $8.95]
FDA awards a new five-year contract to enhance its Sentinel System and prepare it for managing real-world data to improve the safe...[ Price : $8.95]
FDA approves Genentechs Rituxan (rituximab) injection to treat granulomatosis with polyangiitis and microscopic polyangiitis in ch...[ Price : $8.95]
An email distribution by Galt Pharmaceuticals to health professionals draws an FDA Warning Letter on insomnia drug Doral (quazepam...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance on Changes to Existing Medical Software Policies Resulting From Sect...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion cites a Kowa Pharmaceuticals America direct-to-consumer patient testimonial video mont...[ Price : $8.95]
Federal Register notice: FDA announces a 10/31 public meeting on an International Council on Harmonization guideline on clinical t...[ Price : $8.95]
FDA issues new and updated guidances to clarify regulatory oversight of various digital health tools.