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.
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Does The Orphan Drug Act Need A Tune-Up?
A better description of the US FDA’s regulatory flexibility may be necessary, but tinkering with the foundational law for rare disease drug development could open the door for more substantial and unwanted changes.
US FDA May Create Rare Disease Expert Pool For Advisory Committee Reviews
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implying companies are behaving inappropriately, says agency should acknowledge it created problem being addressed in draft guidance.