A voucher program shaves months off of the FDA’s review process for drug development that targets rare pediatric diseases. more→
CREATING HOPE ACT AND PEDIATRIC PRIORITY REVIEW VOUCHERS NEWS
Fast Company praised Kids v Cancer for accelerating the discovery of pediatric cancer treatments. more→
Kids v Cancer was awarded the 2015 Peter F. Drucker Award for Nonprofit Innovation for its role in the 2012 Creating Hope Act. more→
What are the Priority Review Vouchers and how do they benefit the society? more→
How did every parent’s worst nightmare — the death of a child — spur the creation of an incentive system to turn making drugs for childhood cancer from a high-risk, low-reward gamble to a bet a company might make? more→
On December 13, 2016, President Obama signed into law the 21st Century Cures Act, reauthorizing the Creating Hope Act until 2020. more→
U.S. Senate passed the 21st Century Cures Act and with it, reauthorization of the Creating Hope Act. more→
In a vote of 392 – 26, the House passed 21st Century Cures, which includes the Creating Hope Act Pediatric Priority Review Voucher Program. more→
The Creating Hope Act pediatric priority review voucher program is extended until December 31, 2016. more→
Creating Hope Act and Tropical Disease Vouchers Issued and Exercised Please see the CHA PRV vouchers table.
The program rewards companies with a Priority Review Voucher if they develop a drug that gets approved for a rare pediatric condition. more→
Rare pediatric disease Priority Review Voucher fee In fiscal year 2017, the fee is $2,706,000. See Federal Register Notice.
United Therapeutics Corporation announced the sale of its Creating Hope Act priority review voucher to AbbVie for $350 million. United Therapeutics earned the voucher for its development of Unituxin for neuroblastoma, a pediatric cancer. more→
Advocates for children with rare diseases are watching closely a congressional effort to streamline the nation’s drug approval process. more→
Retrophin sells a pediatric priority to Sanofi for $245 million. more→