This week, the FDA released draft guidance to help developers bring promising gene therapies to patients more efficiently by making greater use of existing scientific and regulatory knowledge. The Institute for Gene Therapies (IGT) Chairman Congressman Erik Paulsen issued the following statement: “This is a welcome and practical step forward for patients living with rare and serious diseases who cannot afford to wait. By showing developers how to build on existing CMC, nonclinical, and...
Statement on FDA Draft Guidance to Leverage Prior Knowledge for Gene Therapy Development
msevcik1
