• ExplainersExplainers
    Regulatory NewsRegulatory News

    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 20 December 2019 to include: Merck won a PRV for the approval of its Ebo...
  • ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: FCC Releases Final MBAN Rule (6 October 2014)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FCC Releases Final Rule on Medical Body Area Networks (MBANs) ( FCC ) New FDA Guidance on use of PCR Endpoint to Support Accelerated Approval in Breast Cancer ( FDA ) ( FDA ) Abuse-Deterrence Among New GDUFA Regulatory Science Priorities ( Pink Sheet -$) Takeda loses in lawsuit claiming cancer link t...