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  • Regulatory NewsRegulatory News

    EMA Consults on Regulatory Science Strategy to 2025

    The European Medicines Agency (EMA) on Wednesday launched a six-month public consultation on its proposed strategy for regulatory science through 2025 following two recent multi-stakeholder workshops on the topic.   “The regulatory science strategy to 2025 aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” said EMA Executive Director Guido Rasi, adding that the agency developed the plan with input from t...
  • Regulatory NewsRegulatory News

    FDA Science Board Weighs Plan for 'Cures' Funds

    The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act . Last week, FDA released its proposal for how it would spend the funds ahead of Tuesday’s meeting, with the bulk of the funds to be devoted to sections of the law on "Advancing New Drug Therapies" and "Patient Access to Therapies and Information."...
  • Regulatory NewsRegulatory News

    FDA Unveils Regulatory Science Progress Report

    The report, covering fiscal years 2015 and 2016, notes significant US Food and Drug Administration (FDA) progress in refining non-clinical and clinical tools to better evaluate medical products, advancing manufacturing and quality, and enhancing internal IT tools to support the scientific review of regulatory applications. Non-Clinical In terms of the non-clinical predictive models, the report notes that FDA researchers developed a wide variety of computational tools th...
  • Regulatory NewsRegulatory News

    PMDA Head Talks Priorities for 'Rational Medicine'

    The head of Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Tatsuya Kondo, on Thursday released a paper discussing his vision for a patient-centric, regulatory science-driven and evidence-based system for medicine in Japan. "'Rational Medicine' is the idea that a patient-centric system should be created—a system under which optimal medical care from the patient's point of view, which is based on the latest scientific knowledge, is provided—from the perinatal t...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System A senior politician overseeing the United Kingdom’s exit from the European Union has dismissed the need to retain certain aspects of the country’s current regulatory model post-Brexit. Asked in the House of Commons whether he agreed with industry leaders on the need for the UK to be part of a Europe-...
  • Regulatory NewsRegulatory News

    GDUFA Science Priorities for 2017: Postmarket Evaluation and Complex Generics

    In the final year of the first Generic Drug User Fee Act (GDUFA I), FDA’s Office of Generic Drugs (OGD) is planning to prioritize the post-market evaluation of generics, work on the equivalence of complex generics and locally acting products, as well as new standards and computational and analytical tools. The release of OGD’s regulatory science priorities on Thursday comes as 2016 saw a banner year for generic approvals, with 651 approvals (or 835 if tentative approv...
  • Regulatory NewsRegulatory News

    A Look Into the Future: FDA Wants to Know What’s Coming for Scientific Advances

    New advances in gene editing, precision medicine and synthetic biology are all likely to have a major impact on how the US Food and Drug Administration (FDA) shapes its regulations in the near- and long-term. Now, FDA is formally asking interested parties to offer some fresh perspectives on these and other emerging technologies and cross-cutting scientific advances that could be of importance to FDA, with a focus on areas that may impact FDA in five to 10 years. “FDA's ...
  • RAPS' LatestRAPS' Latest

    RAPS' New Book Offers 36 Articles on Eclectic Science Topics for Curious Readers

    RAPS has just published a new book that offers curious readers a collection of 36 brief, interesting articles on a range of science and regulatory topics, some published for the first time. The new book, Eclectic Science and Regulatory Compliance: Stories for the Curious , by Max Sherman, is a follow-up to his popular 2012 book From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories . Topics Sherman covers in Eclectic Science include mindful...
  • Feature ArticlesFeature Articles

    The Innovation Imperative for Biopharmaceutical Regulatory Science: Three Emerging Trends

    This article discusses how manufacturers' regulatory affairs functions could improve their conduct of regulatory science through adaptive pathways, joint scientific and health technology assessment advice and patient-centricity. The Innovation Imperative for Regulatory Science The US Food and Drug Administration (FDA) defines regulatory science as "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance o...
  • Regulatory NewsRegulatory News

    GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals

    The Government Accountability Office (GAO) on Wednesday released two reports criticizing the Food and Drug Administration (FDA), one that says FDA lacks measurable goals to assess its progress in advancing regulatory science, and another that says FDA should better coordinate between its medical product centers. On the regulatory science front, GAO notes that FDA issued strategic planning documents in 2011 and 2013 to guide its regulatory science and identify priority...
  • Regulatory NewsRegulatory News

    CDRH Unveils Top Regulatory Science Priorities for 2016

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) will look to better leverage big data and advance the use of patient-reported outcomes in regulatory decision making, according to a top 10 list of regulatory science priorities released on Tuesday. The release of the list coincides with the overarching goal of CDRH regulatory science, which is to help develop and apply tools, standards and methodologies to study the safety, eff...
  • Regulatory NewsRegulatory News

    FDA Science Board Calls on Agency to Find New Ways to Stimulate Biomedical Innovation

    The US Food and Drug Administration (FDA) has made “significant strides” in strengthening its scientific capabilities, though there is still some concern about the agency’s ability to support and stimulate biomedical innovation, according to a new report from a subcommittee of FDA’s Science Board. Background Six years after a 2007 report from the Science Board -- which, among other findings, called attention to FDA’s “weak scientific base and inadequate scientific wor...