Gene, Cell Therapy Applications Delayed While FDA Tackles Virus

The Covid-19 pandemic is delaying the FDA’s ability to advance applications for potentially transformative cell and gene therapy treatments, the head of the biologics center’s advanced therapies office said.

The Food and Drug Administration may have to push back meetings for applications that don’t address Covid-19 by a month or two. Agency reviewers also may also have to submit written responses instead of holding teleconferences as they otherwise would have, Wilson Bryan, director of the Office of Tissues and Advanced Therapies in the FDA Center for Biologics Evaluation and Research, said Monday at BIO Digital, the first virtual international ...