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Re: duelittle2 post# 19051

Friday, 07/21/2017 2:48:25 PM

Friday, July 21, 2017 2:48:25 PM

Post# of 64393
https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/howtoapplyfororphanproductdesignation/default.htm

https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525.htm

The Rare Pediatric Disease Priority Review Voucher Program says that a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.



The Pediatric Device Consortia (PDC) Grant Program provides funding to develop nonprofit consortia to facilitate pediatric medical device development.



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