Application Note
Updated US FDA Guidance For The Gene Therapy Industry: Key Changes And Areas Of Increased Focus.
In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. The guidance documents address product development and clinical trial design in general, as well as for specific disease indications.
Several key changes that will impact developers of gene therapies are summarized in this note. Read it to learn more!
