Priority Review Vouchers: Here to Stay and Worth the Effort?
Vice President, Regulatory Policy, NA
Bayer, United States
Priority review vouchers (PRV) have been around since 2007, and the opportunities to earn one have expanded. This session will discuss the value of a PRV, FDA process for awarding them, and things to consider when developing a regulatory strategy.
Learning Objective : Assess the value of a priority review voucher; Evaluate whether a priority review voucher should be incorporated into your development program; Discuss a plan for FDA evaluation of your priority review voucher request.
Andrew Robertson, JD, PhD
Head, Global Regulatory Science and Policy, NA
Sanofi, United States
John Jenkins, DrMed, MD
Principal, Drug and Biological Products
Greenleaf Health, United States
Larry Bauer, MA, RN
Regulatory Scientist, Rare Diseases Program, Office of New Drugs, CDER
FDA, United States