Harvard Professor Questions Success of FDA's Priority Review Voucher Program
By Zachary Brennan -
Published 30 September 2015
As the Senate debates whether to extend or make permanent the US Food and Drug Administration's (FDA) priority review voucher (PRV) program, a Harvard medicine professor says that so far, at least for tropical diseases, there's "little reliable evidence" that the program has spurred novel drug development.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy
Tags: rare disease, tropical disease, priority review, FDA voucher, PRV
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
By Alexander Gaffney, RAC, Michael Mezher, Zachary Brennan -
Published 02 October 2017
Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy, Research and development, Submission and registration
Tags: Priority Review Voucher, PRV, Neglected Tropical Disease, Neglected Tropical Disease Priority Review Voucher, Rare Pediatric Disease Voucher, Rare Pediatric Disease, FDASIA, FDAAA, Voucher, FDA Voucher, Guidance, AbbVie, United Therapeutics, Praluent