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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) 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. Last updated on 25 February 2020 to include: Vifor Pharma said on 17 February that it p...
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    Have PRVs Incentivized New Rare or Neglected Disease Research? Experts Discuss

    The priority review voucher (PRV) programs, created by Congress with an eye to incentivizing the development of new rare pediatric and neglected tropical disease drugs, have so far rewarded a wide range of small and large biopharma companies and products, though whether PRVs have actually spurred new research remains a question. Andrew Robertson, head of regulatory science and policy at Sanofi, and Rachel Cohen, regional executive director for the Drugs for Neglect...
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    Health Advocacy Groups Call for Changes to Priority Review Voucher Program

    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. In a letter addressed to HELP Committee Chairman Lamar Alexander (R-TN) on Tuesday, seven organizations including Médecins Sans Frontières (MSF), Drugs for Neglected Diseases Initiative (DNDi), Center for Global Health Policy, TB Alliance, Treatment Acti...
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    Public Health Groups Propose Global Drug Innovation Fund

    Two health advocacy groups, Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi) are urging public health authorities to create a global fund to tackle what they call "deadly gaps in innovation." Citing the rising threat of antimicrobial resistance (AMR), emerging infectious diseases and neglected tropical diseases (NTDs), the two organizations say the pharmaceutical industry is failing to address certain public health challenges. Back...
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    EMA Says Companies Still Need to Report Side Effects of Donated Drugs

    Drug makers are frequently involved in relief and humanitarian aid efforts, often through donating their products. However, in light of recent outbreaks of neglected tropical diseases such as Ebola, the World Health Organization (WHO) has asked the European Medicines Agency (EMA) to clarify its drug safety monitoring requirements for companies that donate medicines outside the EU to treat neglected tropical diseases. According to WHO, neglected tropical diseases are a...
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    Obama Signs Special Ebola Incentive Program Into Law

    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. The law, Adding Ebola to the FDA Priority Review Voucher Program Act , was signed into law by Obama on 16 December 2013. The law focuses on FDA's neglected tropical disease priority review voucher (PRV) program, a pro...
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    Legislation to Increase Regulatory Incentives to Fight Ebola Awaits Obama's Signature

    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. S.2917 , the  Adding Ebola to the FDA Priority Review Voucher Program Act , passed the US House of Representatives by unanimous consent on 3 December 2013, just one day after the same bill was pas...
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    Ebola Voucher Bill Clears Senate, on Course to Become Law

    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. S.2917, the Adding Ebola to the FDA Priority Review Voucher Program Act , passed the US Senate by unanimous consent on 2 December 2013. "Today the Senate took a strong step to support that mission by pass...
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    US Congress Pushes Ahead With Legislation to Reform FDA Voucher Program

    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. Bill Background The legislation, the Adding Ebola to the FDA Priority Review Voucher Program Act , would make three notable changes...
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    Gilead Makes Record-Setting Purchase of Special FDA Voucher

    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. Background FDA maintains two types of priority review voucher programs, which allow companies to have their products reviewed by FDA in just six months instead of 10. The first and oldest of the voucher types is intended to facilitate development of products ...
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    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...
  • FDA Announces $14 Million in Grants for Trials in Support of Rare Disease Therapies

    The US Food and Drug Administration (FDA) is often seen as a reactive entity-reacting, that is, to the information contained within applications in order to render an approval decision, or to postmarketing adverse event data to determine if a product remains safe for use. But as it illustrated in an announcement made on 21 October 2013, it can also be proactive when it needs to be. FDA said it will be issuing 21 grants through its Orphan Products Grants Program with the...