• Demystifying Regulatory Designations in Drug Development

  • Jul 10 2024
  • Duración: 26 m
  • Podcast

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Demystifying Regulatory Designations in Drug Development

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  • Resumen

  • In this episode, Dr Katherine Bowen and Dr Julie Warner delve into the world of regulatory designations, providing clarity on what these designations offer, the products that qualify, and the pros and cons of each. They discuss the history of regulatory designations, starting with the Orphan Drug Act of 1983, and explore various designations such as Orphan Drug Designation (ODD), Fast Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Regenerative Medicines Advanced Therapy Designation (RMAT).

    Tune in to gain valuable insights from their experience and advice and learn how to navigate the regulatory landscape effectively.
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Enfermedades Físicas Hygiene & Healthy Living Ciencias Biológicas
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