Navigating the FDA’s Draft Guidance on Postapproval Data for Cell & Gene Therapies
In this episode, Rich Gliklich, MD unpacks the FDA’s new draft guidance, Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products.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[…]