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Long-Term Postmarket Studies For Gene Therapies May Need To Be Combined, Standardized

Executive Summary

Running multiple product-specific postmarket trials for 15 years or longer would not be cost-effective and one industry stakeholder suggests workstreams eventually could merge.

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

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.

Gene Therapy Sponsors Risk Additional Work With Late-Stage Manufacturing Changes

Commercial scale-up during Phase III trials could create labeling issues and force additional clinical trials, US FDA officials said.

CBER Director Marks’ Intervention On Sarepta Gene Therapy Filing Decision Appears To Backfire

Former OTAT Director Wilson Bryan says Peter Marks’ order to file Sarepta’s DMD gene therapy application was mainly a public relations move, which does not seem to have worked in the FDA’s favor. Upcoming advisory committee could now involve as much scrutiny of the agency as the application itself.

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