US FDA Struggling With Long-Term Follow-Up Requirements For Gene Therapies

 
• By Derrick Gingery

OTP Director Nicole Verdun acknowledged the agency may need help to determine how to ensure 15 years of patient follow-up is completed despite physician retirements, company closures and other issues that could impact the post-market commitments for gene therapies.

long-term
Many data collection hurdles could arise in the 15-year follow-up period for gene therapy patients. • Source: Shutterstock

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