Woodcock Says Blowing Up Orphan Drug Act Not Advisable In Current Climate
FDA appears just as nervous as the National Organization for Rare Disorders about what Congress would do if asked to tweak the Orphan Drug Act.
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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.
Orphan Exclusivity: Rarely Used, But Well-Known, Loophole Would Be Closed By House Legislation
US FDA could revoke orphan designation or exclusivity if cost recovery requirements were not satisfied under bill unanimously passed by the House Energy and Commerce Committee.
Rare Disease R&D: FDA To Use NIH Registry For Natural History Studies
NIH plans to select two dozen groups to participate in a Global Rare Disease Patient Registry pilot project, which FDA hopes will lead to a better understanding of the conditions and speed drug development.