The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    FDA continues data modernization with new Office of Digital Transformation

    The US Food and Drug Administration (FDA) is moving forward in plans to modernize its data and information technology efforts with the launch of a new Office of Digital Transformation (ODT).   “Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said acting FDA commissioner Janet Woodcock, in a Wednesday press release announcing the newest step in its te...
  • Regulatory NewsRegulatory News

    CDER regulatory science division touts 2020 accomplishments

    In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year.   “2020 was a challenging year. In addition to adjusting to new work environments related to the COVID-19 pandemic that involved 100% teleworking for some staff and laboratory wo...
  • 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 Finalizes Guidance on Emerging Manufacturing Tech Program

    The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing. "In recent years, we've seen significant advances in the modernization of drug manufacturing, including shifts to continuous manufacturing and the first 3D printed drug. These advancements have led to improved products for pa...
  • 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

    FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices

    The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA). Under the guidance, FDA will issue more prompt notifications to the public about medical device "emerging signals," including information that supports a new causal association or a new aspect of a known association between a device and an adverse event, or new information determined by FDA to h...
  • 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...