BIO Ventures for Global Health Documents

• Fact Sheet
• Initial Assessment
• Partnering for Global Health Summary

Key Papers

• Health Affairs, 2006
• Grabowski, Ridley, Moe. Priority Review Vouchers to Encourage Innovation for Neglected Diseases. 2009

Legal Documents

• PRV Legislation
• FDA Draft Guidance
• CDER MAPP

Presentations

• Grabowski et al presentation on priority review vouchers, September 2008
• Tim Cote: Basics of FDAAA, March 2007

Relevant Links

• The Bill & Melinda Gates Foundation
• Food and Drug Administration

BVGH News and Press Releases

• FDA Issues Draft Guidance on Priority Review Vouchers

FDA Contacts

Sponsors with questions are encouraged to contact the appropriate review division within the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

CDER: David Roeder, +1 301-796-0799
CBER: Office of Communications, Training, and Manufacturers Assistance, +1 301-827-1800 or 800-835-4709

Both Centers encourage early interaction with the agency – as early as the pre-IND phase of drug development – to discuss any questions about the program.

Products for neglected tropical diseases may also qualify for orphan drug status. Questions may be directed to Dr. Menfo Imoisili, Office of Orphan Products Development: menfo.imoisili@fda.hhs.gov.