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Orphan Pediatric Loophole To Be Closed By US FDA

 
• By Nielsen Hobbs

Commissioner Gottlieb hopes accomplish through guidance a policy change that advocates failed to get included in user fee legislation passed earlier this year.

The US FDA plans to eliminate a regulatory loophole that has permitted some orphan-designated drugs to avoid pediatric studies. The move, announced by Commissioner Scott Gottlieb, could accomplish through guidance a policy change that advocates failed to get included in the user fee legislation passed earlier this year.

The situation that FDA is hoping to prevent arises if sponsors receive "an orphan designation for a pediatric subtype of...

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