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US FDA Expands Patient Input To New Area: Orphan Grant Applications

 
• By Derrick Gingery

Patient experience will be incorporated into agency orphan grant reviews, and outside rare disease experts will help make decisions.

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Outside experts will help the US FDA's Office of Orphan Products Development review grant applications and patient views will be given to the grant review staff to incorporate into decisions. Both should offer the rare disease community more power over trial designs and FDA's orphan drug research agenda.

OOPD Director Janet Maynard and FDA Patient Affairs Staff Director Andrea Furia-Helms said in a Feb. 28 blog post celebrating Rare Disease Day that the additional patient input will...

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