Search Results for Neglected Tropical Disease

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Health Advocacy Groups Call for Changes to Priority Review Voucher Program By Michael Mezher - Published 19 November 2015

A group of health advocacy organizations are calling on the Senate Committee on Health, Education, Labor and Pensions (HELP) to tighten requirements for obtaining priority review vouchers for drugs for tropical diseases.

Categories: News, Africa, Asia, Latin America and Caribbean, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Research and development

Tags: Neglected Tropical Disease, NTD, Priority Review Voucher, PRV, Senate HELP Committee, MSF, DNDi

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

Obama Signs Special Ebola Incentive Program Into Law By Alexander Gaffney, RAC - Published 18 December 2014

President Barack Obama has signed a new bill into law allowing any pharmaceutical or biotechnology company that successfully develops a product to treat the Ebola virus to obtain a special voucher potentially worth millions—and even billions—of dollars.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Submission and registration

Tags: Ebola, Priority Review Voucher, PRV, Neglected Tropical Disease Priority Review Voucher, Bill, Legislation, Congress, President Barack Obama, Adding Ebola to the FDA Priority Review Voucher Program Act

Legislation to Increase Regulatory Incentives to Fight Ebola Awaits Obama's Signature By Alexander Gaffney, RAC - Published 04 December 2014

The US House has quickly passed legislation making changes to the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular to those developing new treatments for the Ebola virus.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Ebola, PRV, Priority Review Voucher, Neglected Tropical Disease Priority Review Voucher, Bill, Legislation, House, Congress

Ebola Voucher Bill Clears Senate, on Course to Become Law By Alexander Gaffney, RAC - Published 03 December 2014

The US Senate has passed legislation that would overhaul the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus.

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

Tags: Voucher, Ebola, Neglected Tropical Disease Priority Review Voucher, Priority Review Voucher, Tropical Disease Priority Review Voucher, Senate, Legislation, Adding Ebola to the FDA Priority Review Voucher Program Act, Bill

US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program By Alexander Gaffney, RAC - Published 20 November 2014

Both the US House of Representatives and Senate are moving forward with identical pieces of legislation meant to overhaul the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular those developing new treatments for the Ebola virus.

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

Tags: PRV, Priority Review Voucher, Congress, Adding Ebola to the FDA Priority Review Voucher Program Act, Ebola, Neglected Tropical Disease Priority Review Voucher

Gilead Makes Record-Setting Purchase of Special FDA Voucher By Alexander Gaffney, RAC - Published 19 November 2014

The Canadian pharmaceutical company Knight Therapeutics has reportedly sold its Neglected Tropical Disease Priority Review Voucher to Gilead Sciences, making it the first time a tropical voucher has ever been sold.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Tropical Disease Priority Review Voucher, Neglected Tropical Disease Priority Review Voucher, Gilead, Knight Therapeutics, Priority Review Voucher, Voucher Sold

FDA Tries to Invigorate Development of Therapies for 'Neglected' Tropical Diseases By Alexander Gaffney, RAC - Published 16 July 2014

New guidance released earlier this month by the US Food and Drug Administration (FDA) aims to make it easier for some companies to develop products for so-called "neglected" tropical diseases (NTDs) affecting the developing world.

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

Tags: NTDs, Neglected Tropical Disease, Guidance, Tropical Disease Priority Review Voucher