The Priority Review Voucher Program
The Priority Review Voucher Program creates a potentially powerful new incentive for investment in the development of new drugs and vaccines for neglected tropical diseases.
The U.S. Food and Drug Administration will award a priority review voucher (PRV) to the sponsor of a newly approved drug or vaccine that targets a neglected tropical disease such as malaria, tuberculosis, and African sleeping sickness. This voucher, which is transferable and can be sold, entitles the bearer to the priority review for a future new drug application that would not otherwise qualify for priority review – potentially shaving off four to twelve months from the standard FDA review.
Learn more
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Welcome to prvinfo.org
This website is intended to serve as a virtual “hardware store” for PRVs, providing tools for product developers, potential buyers and other interested parties to use to better understand the program and decide whether to take action. On this site you can access the following:
- Information on how the program works, how much a voucher is worth and what products qualify.
- A tracking of vouchers granted and products under development that may be eligible.
- Resources to facilitate the trading of vouchers.
- Program updates, news and events.
- Analysis of program impact.
- Updates from the field and perspectives on PRVs from key thought leaders.
As you use this site, send us your feedback on how to make it of greatest use to you.
Updates
Coartem® Earns First Priority Review Voucher
FDA PRV News
The FDA issued a draft guidance on the implementation of the PRV program [pdf], and solicited input on expanding the list of PRV-eligible diseases. The public meeting to discuss the list expansion took take place on December 12, 2008.
