Orphan Pediatric Loophole To Be Closed By US FDA

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.

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