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Pediatric Testosterone Therapy: Sponsors Wary Of Trials Despite PREA

 
• By Michael Cipriano

Studies are unfeasible, sponsors argue in advance of US advisory committee meeting that could lead to FDA ending its waiver on requiring clinical trials in pediatric patients for new testosterone replacement therapy products.

FDA Advisory Committee Feature image

The US FDA is interested in exploring whether studies of testosterone replacement therapies (TRT) can be conducted in certain pediatric male patients, but sponsors appear to be resistant.

The agency will convene its Pediatric Advisory Committee April 8 for a discussion specifically on the development of replacement testosterone for treatment of primary and secondary hypogonadism due to structural or genetic causes in pediatric patients

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