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Welcome to FDAweb Pay Per View Search our 66,129 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Next >>   FDA Draft Bridging Guidance Out [2748 Words] [ Price : $8.95] FDA publishes a draft guidance recommending how to approach bridging in NDAs or BLAs for some drug-device and biologic-device combination products. 01/02/2020     Demonstrating Effectiveness Guidance for Drugs, Biologics [2751 Words] [ Price : $8.95] FDA issues a draft guidance to help applicants filing NDAs or BLAs or their supplements understand the evidence to be provided to demonstrate effectiveness. 01/02/2020     FDA Approves Padcev for Urothelial Cancer [2731 Words] [ Price : $8.95] FDA approves Astellas’ Padcev, a new type of treatment for advanced urothelial cancer. 01/02/2020     FDA Using National Academies Report on Opioid Prescribing [2843 Words] [ Price : $8.95] FDA says it will use information in a National Academies report to work with medical professional societies on evidence-based guidelines for prescribing opioids for acute pain. 01/02/2020     Affordable Drug Manufacturing Act Reintroduced [2744 Words] [ Price : $8.95] Legislators reintroduce the Affordable Drug Manufacturing Act to help lower drug costs. 01/02/2020     Trump Proposes Some Drug Imports from Canada [2792 Words] [ Price : $8.95] The Trump administration proposes allowing importation of certain prescription drugs from Canada by states, wholesalers, pharmacists, or non-federal government entities. 01/02/2020     FDA Gabapentinoid Safety Communication [2740 Words] [ Price : $8.95] FDA says patients with respiratory risk factors may be at risk for serious breathing difficulties if they use any of the gabepentinoid drugs. 01/02/2020     Is FDA Promoting Off-Label Uses? [2915 Words] [ Price : $8.95] Attorney James Beck says FDA is breaking with long-established practice to encourage truthful promotion to doctors of off-label uses of FDA-approved drugs through its new CURE ID program. 01/02/2020     Latest FDA Warning Letters [1235 Words] [ Price : $8.95] FDA Webview posts summaries of the FDA Warning Letters released during our holiday break. 01/02/2020     Generic Drug Competition Lowers Prices: FDA Analysis [2752 Words] [ Price : $8.95] An updated FDA analysis shows that an increase in generic drug competition leads to a decrease in generic drug prices. 01/02/2020     << Prev  4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23  Next >>

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