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# FDA Lifts Hold on Sarepta Gene Therapy Clinical Hold
- URL: https://www.fdaweb.com/fda-lifts-hold-on-sarepta-gene-therapy-clinical-hold/
- Published: 2018-09-24T12:00:00.000Z
- Updated: 2026-09-15T00:33:39.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5142428

FDA has lifted a clinical hold against Sarepta Therapeutics against the company’s Duchenne muscular dystrophy micro-dystrophin gene therapy program. The hold was placed in July due to the presence of trace amounts of DNA fragment in research-grade third-party supplied plasmid in a manufacturing lot. “In response, and in collaboration with Nationwide Children’s Hospital, an action plan was developed and submitted to the FDA, including an audit of the plasmid supplier and a commitment to use GMP-s plasmid for all future production lots,” the company says. “Our focus now is on meeting with the \[drug review\] Division to take guidance and gain alignment around what we hope to be our registration trial for our micro-dystrophin program and achieving our goal of commencing that trial by year-end 2018.”