Not A Loophole? BIO Concerned About Limiting Orphan Designations For Pediatric Subsets of Common Diseases
BIO disagrees with US FDA implying companies are behaving inappropriately, says agency should acknowledge it created problem being addressed in draft guidance.
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Drug sponsors tell US GAO that orphan incentives don't draw them to the space, and several stakeholders say high prices and scientific discovery are the reason for the sector's growth.
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US FDA's draft guidance closes loophole where sponsors could obtain an orphan designation for a pediatric subset and then be exempt from requirements to conduct pediatric studies.