FDA Guidance for Rare Pediatric Disease Priority Review Vouchers


The FDA’s draft guidance helps developers of rare pediatric disease products in identifying whether their product may be eligible for rare pediatric disease designation and a rare pediatric disease priority review voucher.

It also sets out the process for applying for such designations and vouchers, sponsor responsibilities on approval of a rare pediatric disease product application, and the considerations when using and transferring a rare pediatric disease priority review voucher.

Whilst guidance on vouchers is being welcomed by companies developing desperately needed drugs in niche indications, they also do raise ethical questions regarding the use of incentives. 

The draft guidance can be viewed by clicking here.

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