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Podcast: Orphan Drug Designations and Orphan Subsets

Regulatory Consulting Regulatory Submissions

Sponsors developing drugs or biologics intended to prevent, diagnose, or treat a rare disease or condition should consider applying for the Orphan Drug Designation (ODD) program with the FDA. The FDA’s Orphan Drug Designation program is meant to encourage the development of therapies for rare diseases and provides incentives for orphan products including exemption from user fees, a potential for 7 years of market exclusivity, and tax credits for some clinical trials.

Listen to the full episode on Veristat’s Advancing Revolutionary Therapies (ART) Podcast to learn more about Orphan Drug Designation classification and the strategic use of orphan subsets in study design.

Learning Points

  • Orphan Drug Designation criteria
  • What makes a subgroup of a disease ‘inappropriate’ or ‘scientifically justified’ for orphan drug designation?
  • Scenario examples of how to determine a ‘scientifically justified' orphan subgroup.

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