• Regulatory NewsRegulatory News

    Tropical Disease Priority Review Voucher Fee Set to Rise

    The US Food and Drug Administration (FDA) is set to increase the fee it charges users of a special, transferable voucher meant to reward developers of tropical disease treatments with an expedited review process for any subsequent drug product. Background The voucher, known as a tropical disease priority review voucher, was established under the FDA Amendment Act of 2007 (FDAAA) . Under the law, companies that receive approval for a tropical disease treatment are eligi...
  • Regulatory NewsRegulatory News

    FDA Voucher for Accelerated Drug Review up for Sale

    • 13 August 2014
    Hot on the heels of the first ever sale of a pediatric review voucher for a whopping $67 million, Canadian pharmaceutical manufacturer Knight Therapeutics announced Tuesday (12 August) that it plans to auction off a similar voucher of its own. FDA currently maintains two priority review voucher systems: one known for tropical diseases, and the other for pediatric rare diseases. Background: Tropical Disease Vouchers The  tropical disease priority review voucher system...
  • Regulatory NewsRegulatory News

    First Pediatric Priority Review Voucher Goes up for Sale, Fetching $67M

    As far as regulatory incentives go, some are pursued more than others. The US Food and Drug Administration's (FDA) orphan drug exclusivity provisions, for example, have brought about a renaissance of therapies meant to treat patients suffering from rare diseases and conditions. But on the other side of the coin are incentives not often sought out by companies. And perhaps no incentive maintained by FDA is used less than its priority review vouchers. Background: Vouchers...
  • Regulatory NewsRegulatory News

    FDA Tries to Invigorate Development of Therapies for 'Neglected' Tropical Diseases

    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. Background Tropical diseases are typically not subject to the same levels of investment and research as are other diseases, in part because the markets for those products are generally less affluent, leaving companies less able to obtain...
  • Regulatory NewsRegulatory News

    FDA Planning Five Guidance Documents to Help Children With Rare Diseases

    • 10 July 2014
    The US Food and Drug Administration (FDA) has released a new report indicating four core ways it plans to accelerate the development of treatments for pediatric rare diseases (PRD). The report, Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases , was required under Section 510 of the Food and Drug Administration Safety and Innovation Act ( FDASIA ) and based off a...
  • FDA Slashes Fees for Priority Review Voucher

    The US Food and Drug Administration (FDA) has announced the release of fee rates for using tropical disease priority review vouchers for the upcoming year, slashing fees more than 32% from 2012. The tropical disease voucher system was established under the FDA Amendment Act of 2007 (FDAAA) , which authorized a novel program. Under it, companies that receive approval for a tropical disease treatment are eligible to receive a transferrable voucher that allows the bear...