FDA Issues Guidance to Accelerate Cell and Gene Therapy Development
The FDA has released draft guidance aimed at expediting the development of cell and gene therapies (CGT) by allowing developers to utilize existing scientific knowledge to streamline regulatory submissions. This initiative is part of a broader effort by the FDA to reduce barriers for CGT sponsors, particularly for diseases with limited treatment options. The guidance encourages the use of publicly available data and established knowledge, such as chemistry, manufacturing, and controls (CMC) data, to facilitate faster approval processes. The FDA's acting director of the Center for Biologics Evaluation and Research, Karim Mikhail, emphasized the importance of this guidance in delivering safe and effective therapies to patients with rare and life-threatening diseases. 
