Introduced in Senate (07/28/2015)
Advancing Hope Act of 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers.
The voucher program is extended by removing the provision terminating the program one year after the Food and Drug Administration’s (FDA’s) issuance of three rare pediatric disease vouchers.
A voucher may not be issued for a rare pediatric disease product if a voucher was issued for the product as a tropical disease product.
A drug sponsor that intends to request a voucher for a rare pediatric disease drug must notify the FDA of that intent upon submission of the new drug application.