Navigation Links
FDA Issues Draft Guidance on Priority Review Vouchers
Date:10/20/2008

-BIO Ventures for Global Health to Work with Industry to Educate, Promote PRV Program-

WASHINGTON, Oct. 20 /PRNewswire-USNewswire/ -- BIO Ventures for Global Health (BVGH) today announced its support of the US Food and Drug Administration's (FDA) release of Draft Guidance for Industry on Priority Review Vouchers. The Priority Review Voucher (PRV) program is designed to encourage industry investment in the development of drugs and vaccines for neglected tropical diseases. Enacted as part of the FDA Amendments Act, the program awards a Priority Review Voucher to any sponsor obtaining FDA approval for a product preventing or treating diseases such as malaria, tuberculosis and leishmaniasis. The voucher, which can be traded or sold, can be used to obtain priority review on a future product of the company's choosing, shaving months off the standard FDA review.

Barriers such as insufficient markets, funding, and information have largely deterred industry from applying their technologies to research and development in this arena. PRVs can help industry overcome some of these barriers.

"Priority Review Vouchers are valuable incentives that leverage industry expertise and encourage greater investment in innovation for neglected tropical diseases," said Christopher D. Earl, president and CEO of BVGH. "By taking advantage of existing market forces, patients in the developing world can have faster access to lifesaving products that may not otherwise be developed. And sponsors of neglected disease drugs can be rewarded for their innovations."

Some economists estimate that a voucher may be worth hundreds of millions of dollars - an amount sufficient to offset the substantial risk and investment required for discovery and development of a new neglected disease product.

"Industry and investors alike are keenly following the implementation of the PRV program," said Wendy Taylor, founder and vice president of strategy and operations at BVGH. "The timely release of this guidance reinforces FDA's support of this important program."

A key aspect of the voucher is its ability to be traded or sold. The guidance confirms that contractual agreements directing the right to transfer vouchers can allow for an unlimited number of transfers before the voucher is used.

BVGH's support for PRVs stems from the organization's core mission in developing market-based incentives for investment in global health. BVGH is continuing its advocacy with industry and communication with all stakeholders to ensure that the PRV program grows into a powerful incentive for building the arsenal of new medicines for global health.

About BVGH

BIO Ventures for Global Health (BVGH), a non-profit organization, is harnessing the resources of the biotechnology industry to create new medicines for neglected diseases of the developing world. Our mission is to break down barriers that hinder industry involvement in global health product development and to catalyze new industry investment. For further information visit the BVGH website at: http://www.bvgh.org.


'/>"/>
SOURCE BIO Ventures for Global Health
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Resverlogix Issues a Management Statement
2. SectorWatch.biz Issues MarketStats on Agri-Biotech Equities YGYB, GRO, SEED, MON, ADM, and BG
3. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Generex Biotechnology Corporation
4. BeaconEquity.com Issues Trade Alerts on Biotechnology Stocks: ELN, PFE, AMGN, DNA, BIIB, GILD
5. Arbitration Panel Issues Ruling in Distribution Dispute
6. ActivBiotics Assignee Issues First Distribution of Cash to Creditors
7. Neuftec Issues Patent Infringement Proceedings in the UK Against Oxonica
8. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Arana Therapeutics Ltd.
9. Bristol-Myers Squibb Issues $1.6 Billion of Senior Notes
10. SectorWatch.biz Issues MarketStats on KBLB, DGX, LH, BRLI, and ABT
11. VaxGen Issues Rebuttal to MedCap Letter
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... , December 2, 2016 The immunohistochemistry ... growing at a CAGR of 7.3% during the forecast period of ... and diagnostic laboratories segment accounted for the largest share of immunohistochemistry ... ... on global immunohistochemistry (IHC) market spread across 225 pages, profiling 10 ...
(Date:11/30/2016)... CA (PRWEB) , ... November 30, 2016 , ... ... a new moving magnet Voice Coil Actuator with a flexure design that ensures ... long life with cost-effective pricing and is ideally suited where extreme precision is ...
(Date:11/30/2016)... York , November 30, 2016 ... as a few players hold a dominant share in ... Charles River Laboratories International, Inc., and Merck KGaA, held ... in 2015. Transparency Market Research observes that these companies ... focused on development products that are do not require ...
(Date:11/30/2016)... , Nov. 30, 2016 Biotest Pharmaceuticals ... is pleased to announce the addition of its newest ... Kearney, Nebraska . The 15,200 square foot ... November 29th, 2016 and brings the total number of ... Ileana Carlisle , BPC,s Chief Executive Officer said ...
Breaking Biology Technology:
(Date:6/9/2016)... , June 9, 2016  Perkotek an innovation leader in attendance control systems ... seamlessly log work hours, for employers to make sure the right employees are actually ... http://photos.prnewswire.com/prnh/20160609/377486LOGO ... ... ...
(Date:6/2/2016)... , June 2, 2016 The Department ... has awarded the 44 million US Dollar project, for the ... Vehicle Plates including Personalization, Enrolment, and IT Infrastructure , ... in the production and implementation of Identity Management Solutions. Numerous ... however Decatur was selected for the ...
(Date:5/24/2016)... , May 24, 2016 Ampronix facilitates superior patient care by providing unparalleled ... medical LCD display is the latest premium product recently added to the range of ... ... ... Sony 3d Imaging- LCD Medical Display- Ampronix News ...
Breaking Biology News(10 mins):