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Orphan Drug Policy Changes To Be Considered Under US FDA's FY 2019 Budget Proposal

 
• By Derrick Gingery

Proposed $20m funding boost for rare disease development includes review of orphan incentives, including how to potentially stimulate development in ultra-orphan diseases.

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A review of potential ultra-orphan incentives in the US FDA's fiscal year 2019 budget request may signal a change in its approach to the space.

The agency requested an additional $20m for "stimulating medical product development for rare diseases" in its FY 2019 budget...

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