Key Takeaways
- The FDA’s recent cell and gene therapy FAQ draft guidance has triggered more questions about when sponsors should request an INTERACT meeting versus a pre-IND meeting.
- PhRMA and BIO seek clarity on whether surrogate endpoints used for accelerated approval of small molecules are appropriate for cell and gene therapies.
- Industry groups also want the expectation for 15-year long-term follow-up relaxed, particularly for CAR-T products.
A US Food and Drug Administration guidance aimed at clarifying the difference between INTERACT and pre-IND meetings seems to have prompted even more confusion among cell and gene therapy sponsors...
Industry comments on the November 2024 guidance, “Frequently Asked Questions – Developing Potential Cellular and Gene Therapy Products,” also seek clarity on whether and how surrogate endpoints used for small...