FDA expects 51 rare pediatric disease designation requests and 20 priority review voucher requests annually. more→
CREATING HOPE ACT & PEDIATRIC PRIORITY REVIEW VOUCHERS NEWS
Priority Review Voucher Sold for $105 million
The PRV program, established under the Creating Hope Act in 2012, encourages development of new drug and biological products for rare pediatric diseases. more→
Climb the Hill Youth Advocacy Day — Why Do I Do It?
Watch our youth advocates and cancer survivors describe their meetings with congressional staffers and advocating for kids with cancer. more→
Priority Review Vouchers for rare pediatric diseases issued and exercised
Everything you need to know about FDA’s Priority Review Vouchers (RAPS Regulatory Explainer)
What are the Priority Review Vouchers and how do they benefit the society? more→
The death of a child and a golden ticket for drug makers (STAT)
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→
Creating Hope Act reauthorized in 21st Century Cures (KVC Newsletter)
On December 13, 2016, President Obama signed into law the 21st Century Cures Act, reauthorizing the Creating Hope Act until 2020. more→
Congress passes CURES and reuthorizes the Creating Hope Act, 94-5! (KvC Newsletter)
U.S. Senate passed the 21st Century Cures Act and with it, reauthorization of the Creating Hope Act. more→
The House reauthorized the Creating Hope Act (KvC Newsletter)
In a vote of 392 – 26, the House passed 21st Century Cures, which includes the Creating Hope Act Pediatric Priority Review Voucher Program. more→
President Obama signs the Advancing Hope Act to extend the Creating Hope Act to December 31, 2016 (KvC Newsletter)
The Creating Hope Act pediatric priority review voucher program is extended until December 31, 2016. more→
How one drug company fast-tracked the FDA’s review process (PBS News Hour)
A voucher program shaves months off of the FDA’s review process for drug development that targets rare pediatric diseases. more→
Rep. McCaul urges reauthorization of Priority Review Voucher program (Rare Disease Report)
The program rewards companies with a Priority Review Voucher if they develop a drug that gets approved for a rare pediatric condition. more→
Kids v Cancer is #4 of Fast Company’s Top 10 most innovative companies in not-for-profit (KvC Press Release)
Fast Company praised Kids v Cancer for accelerating the discovery of pediatric cancer treatments. more→
Priority Review Voucher fees 2014-2017
Rare pediatric disease Priority Review Voucher fee In fiscal year 2017, the fee is $2,706,000. See Federal Register Notice.
Another Creating Hope Act voucher sold! (KvC Newsletter)
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→