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Tag: ANDA submissions

  • 23 Dec
    Bioequivalence Waivers: When the FDA Allows In Vitro Data Instead of Human Studies

    Bioequivalence Waivers: When the FDA Allows In Vitro Data Instead of Human Studies

    The FDA allows bioequivalence waivers for certain generic drugs when in vitro dissolution tests prove they behave like brand-name versions-saving time, money, and avoiding unnecessary human trials. Learn when and how this science-based shortcut works.
    By: Jarrett Kingsbury 15 Comments Read More

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