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Not A Loophole? BIO Concerned About Limiting Orphan Designations For Pediatric Subsets of Common Diseases

 
• By Derrick Gingery

BIO disagrees with US FDA implying companies are behaving inappropriately, says agency should acknowledge it created problem being addressed in draft guidance.

Guidance word in red keyboard buttons

The Biotechnology Innovation Organization took offense with the US FDA's suggestion that sponsors are exploiting a "loophole" in the Orphan Drug Act to gain an exemption from pediatric studies that otherwise would be mandated.

In comments to recent draft guidance stating that FDA would limit orphan designations in those situations, BIO argues that...

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