FDA Increases Manufacturing Flexibility for Cell and Gene Therapies. Clinical and commercial quality controls are simplified. The FDA is trying to speed up approval of treatments in areas where there is unmet need. It issued draft guidance entitled "Frequently Asked Questions - Development of Potential Cell and Gene Therapy Products", which is 40 pages long. The document provides insight into best practices for common questions of the Office for Therapeutic Products. Regulators recognize the potential of CGT and offer scientific advice, including CMC. Early FDA involvement allows flexibility for manufacturing changes without full revalidation. The START pilot program shortened development by several years due to communication with the FDA.[2][3]