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Sarepta Trial Protocol Change Could Spur More IRB Referrals To US FDA

 
• By Sue Sutter

Investigational review boards might be more inclined to bring pediatric study design issues to FDA’s attention for public review following agency’s quick decision to allow in-dwelling ports for patients in Sarepta’s placebo-controlled ESSENCE trial.

The US FDA’s speedy decision to allow in-dwelling ports in a Sarepta Therapeutics Inc. Duchenne muscular dystrophy (DMD) trial could encourage greater use of the investigational review board (IRB) referral process for pediatric studies.

In a May 25

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