FDA Encourages Telemedicine For Gaps in Gene Therapy Trials

The U.S. Food and Drug Administration (FDA) is encouraging sponsors involved in gene therapy trials to fill data gaps with remote visits and telemedicine. The encouragement comes from Wilson Bryan, the FDA’s OTAT (Office of Tissues and Advanced Therapies) during the American Society of Gene and Cell Therapy meeting on May 12, and is in response to companies requests for changing study parameters due to a decreasing amount of participant enrollments. The FDA has expressed its hesitancy in modifying these parameters for fear of jeopardizing the integrity of the clinical trials.

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