FDA To Offer Reviewers Rare Disease Training; Patient Groups Want Separate ODE
Executive Summary
FDA will offer training next year for reviewers to better understand rare diseases and their associated product applications that could help speed the approval process, although it appears to be optional.
You may also be interested in...
Does The Orphan Drug Act Need A Facelift? Advocates Consider Changes
Rare disease advocates are wondering whether it may be time to strengthen the Orphan Drug Act and at least one organization is researching potential improvements that could be made to the pathway.
Does The Orphan Drug Act Need A Facelift? Advocates Consider Changes
Rare disease advocates are wondering whether it may be time to strengthen the Orphan Drug Act and at least one organization is researching potential improvements that could be made to the pathway.
Rare Disease Improvements Planned Soon, And Up To Five Years From Now
FDA has short- and long-term plans to improve its rare disease program under PDUFA V, and next month the agency will continue its efforts to boost drug development in the sector.