Search Results for Rare Pediatric Disease Voucher

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Priority Review Voucher Fees to Decline in FY 2017 By Zachary Brennan - Published 29 September 2016

The US Food and Drug Administration (FDA) on Thursday unveiled the new user fee rates for the tropical disease and rare pediatric disease priority review voucher (PRV) programs. The additional fees necessary to use the vouchers for both programs are set to decline by about $20,000 when compared to last year.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs

Tags: priority review vouchers, PRV, rare pediatric disease voucher, golden ticket, tropical disease priority review voucher

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

FDA Explains How its New Incentive Program for Rare Pediatric Disease Treatments Works By Alexander Gaffney, RAC - Published 18 November 2014

The US Food and Drug Administration (FDA) has released a long-anticipated guidance document intended to explain how a new incentive program known as the Rare Pediatric Disease Priority Review Voucher system works.

Categories: News, US, FDA, Biologics and biotechnology, Drugs

Tags: Rare Pediatric Disease Priority Review Voucher, FDASIA, Voucher, Rare Pediatric Disease Voucher, Priority Review Voucher, Guidance, Draft Guidance