Welcome to Conversations in Drug Development, brought to you by the team at Boyds. This podcast is for our fellow community of scientists and clinicians working in the wonderful world of cell and gene therapy and drug development.
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Welcome to Conversations in Drug Development, brought to you by the team at Boyds. This podcast is for our fellow community of scientists and clinicians working in the wonderful world of cell and gene therapy and drug development.
Demystifying Regulatory Designations in Drug Development
Conversations in Drug Development
25 minutes 53 seconds
1 year ago
Demystifying Regulatory Designations in Drug Development
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.
Conversations in Drug Development
Welcome to Conversations in Drug Development, brought to you by the team at Boyds. This podcast is for our fellow community of scientists and clinicians working in the wonderful world of cell and gene therapy and drug development.
