Are Orphan Incentives Necessary For Development? Sponsors Aren't So Sure
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.
You may also be interested in...
FDA's Peter Stein calls idea "useful"; rare disease experts would temporarily serve on standing advisory committees when needed.
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implying companies are behaving inappropriately, says agency should acknowledge it created problem being addressed in draft guidance.
Non-profit biotech founder says permanent pediatric rare disease priority review voucher program will boost incentive, but FDA is concerned about resource drain vouchers cause.