CMC Considerations for CAR T Cell Product Development
The FDA's Role in Gene Therapy
74th Cellular, Tissue, and Gene Therapies Advisory Committee
The Promises and Pitfalls of Gene Therapy for Rare Diseases
MEDIA CALL: FDA Approves First Gene Therapies to Treat Sickle Cell Disease – 12/08/2023
Understanding the FDA Approval Process for Gene Therapies: Step-by-Step Explanation
An Update on the Office of Cellular, Tissue and Gene Therapies: Celia Witten, FDA
"Gene Therapy- Unlocking the Promise" Peter Marks, FDA
Regulatory considerations for Cell and Gene Therapies - Jim DeKloe
75th Cellular, Tissue, and Gene Therapies Advisory Committee
Gene Therapy Inside Out
Peter Marks on FDA Regulation of CRISPR, Gene Therapies
Cell and Gene Therapy: Advancing the Next Generation of Pharmaceuticals
FDA’s Efforts to Advance the Development and Approval of Cellular and Gene Therapies
FDA Regulation of Cell and Gene Therapies: Facilitating Advanced Manufacturing
FDA Regulatory Education for Industry (REdI) – Biologics Track
Cell & gene therapies more likely to receive FDA approval: ARM Studios interview with Mark Trusheim
Are the FDA’s Gene Therapy Guidances Good for Business?
A 7-Year-Old's Blindness was Reversed by the 1st FDA-Approved Gene Therapy for Retinal Degeneration
FDA approves 'gene therapy' leukemia treatment