Association of the priority review voucher with neglected tropical disease drug and vaccine development

JAMA - Journal of the American Medical Association

Volumn 318, Issue 4, 2017, Pages 388-389

  Jain, Nina ^a   Hwang, Thomas ^a   Franklin, Jessica M ^a   Kesselheim, Aaron S ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG INDUSTRY; DRUG MANUFACTURE; FINANCIAL MANAGEMENT; HUMAN; LEGISLATION AND JURISPRUDENCE; PHASE 1 CLINICAL TRIAL (TOPIC); STATISTICS AND NUMERICAL DATA; TROPICAL MEDICINE; UNITED STATES;

CLINICAL TRIALS, PHASE I AS TOPIC; DRUG INDUSTRY; FINANCING, GOVERNMENT; HUMANS; ORPHAN DRUG PRODUCTION; TROPICAL MEDICINE; UNITED STATES;

EID: 85027571860     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2017.7467     Document Type: Article

References (5)

1. US Food and Drug Administration. Tropical disease priority review vouchers: guidance for industry. https://www.fda.gov/downloads/Drugs/.../Guidances/UCM080599.pdf. Accessed December 21, 2016.
2. Kesselheim AS, Maggs LR, Sarpatwari A. Experience with the priority review voucher program for drug development. JAMA. 2015;314(16):1687-1688.
3. US Food and Drug Administration. FDA approves vaccine to prevent cholera for travelers. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm506305.htm. Accessed May 10, 2017.
4. Pharma Intelligence. Pharmaprojects. https://pharmaintelligence.informa.com/products-and-services/data-and-analysis/pharmaprojects. Accessed June 30, 2016.
5. Ridley DB, Régnier SA. The commercial market for priority review vouchers. Health Aff (Millwood). 2016;35(5):776-783.