In this episode, Rich Gliklich, MD unpacks the FDA’s new draft guidance, Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products. Aimed at enhancing long-term safety and efficacy monitoring, the guidance focuses on:

  • The importance of long-term follow-up
  • Cautioning on the use of typical real-world data sources such as medical claims and EHR records
  • Emphasizing the importance of registries and decentralized clinical trial models as a primary tool for data collection

Tune in for practical considerations for sponsors and expert insights on compliant, cost-effective postapproval data strategies.

 

 

Speaker

 

Rich Gliklich, MD
Founder, OM1