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FDA Issues Draft Guidance on Priority Review Vouchers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Ventures for Global Health (BVGH) today announced its support of the US Food and Drug Administration's (FDA) release of Draft Guidance for Industry on Priority Review Vouchers.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.
'/>"/>

SOURCE BIO Ventures for Global Health
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

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:1/15/2014)... , January 15, 2014 A study has ... on the Formula 1 track could help to tackle the ... Technologies (MAT), Stowhealth (a GP surgery based in Stowmarket) and ... provider Simplyhealth. Telemetry technology, which is inspired by ...
(Date:1/15/2014)... 15, 2014 Two champions of science, ... sponsorship of an annual competition for middle and high ... to, innovative STEM study. The competition presents students with ... of Engineering Aptitude, Mathematics, and Sciences is a ...
(Date:1/15/2014)... DTS Language Services, Inc . is pleased to ... Science organizations who need document translations. Clients will now ... documents in advance with a selection of nearly 50 life ... a critical factor in clinical and scientific fields, and decrease ...
(Date:1/15/2014)... Sunnyvale, CA (PRWEB) January 15, 2014 ... throughput research solutions, today announced that Lupin Limited, one ... of Freeslate’s CM Protégé PharmD System for ... in Mumbai, India, is focused on a wide range ...
Breaking Biology Technology:Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 2Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 3Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 4Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 2Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 3Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 4Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 5DTS Improves Efficiency for Life Science Document Translations 2Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 2Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 3
... mission statement, consider this pledge from the bipartisan Wisconsin School ... dollars on top of current dollars, but propose a complete ... the (K-12 public school) system, and then any additional dollars ... , [Tom Still is a member of the initiative] ...
... President George Bush today spoke of energy during ... traditional energy resources, his remarks were directed toward new ... to foreign oil. , ,In an address before employees ... is developing a new fuel cell for hybrid automobiles, ...
... Eau Claire, Wis. The Eau Claire Area ... again, offering cash awards of up to $10,000 to the ... entrepreneurs, the EDC is holding a business planning seminar on ... Business Contest will have until May 26 to prepare ...
Cached Biology Technology:Measuring what works and what doesn't in the prototypical school 2Measuring what works and what doesn't in the prototypical school 3Bush praises Johnson Controls battery tech in Milwaukee visit 2
(Date:4/17/2014)... Stem cells in bone marrow need to produce hydrogen ... tissue, according to a new study from the Center ... of Dentistry of USC. , Professor Songtao Shi, principal ... sulfide produced by the cells governs the flow of ... cellular signals that results in osteogenesis, or the creation ...
(Date:4/17/2014)... German . ... demanded of him, he can expect his premises to be ... of the consequences is enough to make restaurant owners pay ... lay their eggs in other birds, nests. If the host ... their revenge by destroying the entire nest. Consequently, it is ...
(Date:4/17/2014)... France have hit on a novel method to ... correct and most effective treatment possible., Kidney stones ... and developing world. If left untreated, apart from ... failure and other complications. In many patients treated ... a more effective pathological approach to diagnosis and ...
Breaking Biology News(10 mins):Fear of the cuckoo mafia 2Fear of the cuckoo mafia 3
... Humans have used the papyrus sedge for millennia. The Ancient ... buoyant boats, it is grown for ornamentation and parts can ... of Environmental Technology and Management , researchers in Uganda have ... toxins and other noxious residues from abattoir effluent. Robinson ...
... A team of UC Davis scientists has found that ... combat cancer by cutting off the supply of oxygen and ... The scientists report their discovery in the ... ). The groundbreaking study was a collaboration among multiple UC ...
... especially in rural areas, may interfere not only with ... finding flowers, according to researchers from Penn State and ... to perniciously alter key interactions between plants and animals," ... Environmental Research Letters . The animal tested in this ...
Cached Biology News:Papyrus plant detox for slaughterhouses 2Fatty acid metabolite shows promise against cancer in mice 2Fatty acid metabolite shows promise against cancer in mice 3Ozone masks plants volatiles, plant eating insects confused 2
... a powerful technology platform that automates gel ... High quality sample preparation can be carried ... Xcise is a powerful technology platform that ... analysis. It combines the functions of high-resolution ...
Request Info...
... compatible with hood installations. ... system for 384-well plates, ... prepares large quantities of ... Wellpro also performs plate ...
... is a new generation bulk reagent dispenser ... simplicity for pharmaceutical and biotech laboratories. Based ... range, Multidrop Combi has been designed for ... 0.5-2500 l and multiple plate types including ...
Biology Products: