3 Takeaways From FDA Cell And Gene Therapy Draft Guidance

Brigid Bondoc, Karen Potter, and Liz Newman published an article in Law360 that discussed the U.S. Food and Drug Administration's (FDA) recent draft guidance documents, which provided regulatory framework for cell and gene therapies (CGTs).

The authors noted that the FDA is prioritizing the regenerative medicine advanced therapy designation in the updated expedited programs guidance. The FDA is also signaling that post-approval data collection will be required for CGT products, as well as a preference for innovative trial designs.

Read the full article.