Public Comment | Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause | April 27, 2026 Share
Peer Review | Enabling access to genetically modified cell therapies through flexible approaches to manufacturing and cost recovery | December 2, 2025 Share
Public Comment | FDA CBER OTP Public Listening Meeting – Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies | September 16, 2025 Share
Peer Review | Intentional heterogeneity in autologous cell-based gene therapies: strategic considerations for first-in-human trials | June 9, 2025 Share
White Paper | Regulatory and Manufacturing Pathways to Expand Access to Genetically Modified Cell Based Therapies | May 8, 2025 Share
RFI | Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee | August 2, 2024 Share
Public Comment | Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings | August 1, 2024 Share
Peer Review | Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products | March 15, 2024 Share
