Home > Blog > Orphan drug designations and orphan subsets podcast

1 min read

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.

LISTEN TO PODCAST

 

 Meet Veristat. Learn More. 

2 min read

2nd Annual Clinical Outsourcing Group CRO Summit

Oct 17, 2025  Veristat Events

Meet Veristat at 2nd Annual Clinical Outsourcing Group CRO Summit December 2-3, 2025

Veristat is proud to participate...

2 min read

Outsourcing in Clinical Trials New England

Oct 2, 2025  Veristat Events

Meet Veristat at Outsourcing in Clinical Trials New England

Veristat is excited to participate in the 17th Annual...