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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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.
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.
CDER Director Janet Woodcock says rare disease advocates should consider organizing patients to study a rare disease history and progression.