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  • Regulatory NewsRegulatory News

    Evaluating Next-Generation Sequencing: From Design Concept to Performance Standards

    Discussions are underway on how the US Food and Drug Administration (FDA) plans to develop new ways of regulating next-generation sequencing (NGS) diagnostics. Kicking off a two-day public workshop today, FDA Commissioner nominee Robert Califf said that NGS tests hold great promise for patients, but still present "tremendous uncertainty." The issue, he said, is determining "how accurate [and] how useful can we make the predictions that come from these tests." Califf als...
  • Regulatory NewsRegulatory News

    How Should Diagnostic Tests be Regulated? Congress Wants to Know

    A new white paper published by the House Energy and Commerce Committee is calling for feedback on the US Food and Drug Administration's (FDA) proposal to regulate laboratory developed tests (LDTs) more similarly to how they regulate in vitro diagnostics. Background Under a longstanding regulatory exemption, lab-developed tests—products developed and used within a single laboratory—have not been subject to FDA’s premarket controls. Instead, the products are subject to th...
  • Regulatory NewsRegulatory News

    Is a Drug Unsafe or Just Unprofitable? How a Lack of Data Clouds Regulatory Classifications

    Regulatory professionals are frequently concerned with getting pharmaceutical products approved for use and available to consumers. But as a new paper in the Journal of the American Medical Association (JAMA) explains, the way in which drug products are withdrawn from the market can have significant implications for both regulators and patients as well. Background Writing in JAMA Internal Medicine , Vinay Prasad, an official associated with Johns Hopkins University...
  • Regulatory NewsRegulatory News

    AHWP Finalizes Document Meant to Form Backbone of Software Regulation Approach

    The medical-device focused Asian Harmonization Working Group (AHWP) has released a new document meant to eventually help provide a common approach for the regulation of medical device software. The draft version of the document was released in July 2014, and provided a high-level overview of the regulatory approaches taken by major economies--the US, EU, Australia and China—toward the regulation of software as a medical device (SaMD). The overall goal of the white pa...
  • EMA Continues to Seek Guideline on Similarity Criteria for Biosimilars

    The European Medicines Agency (EMA) has formally issued a call for a reflection paper on methods to compare quality attributes in drug development, saying that regulators need to settle on established criteria for determining acceptable ranges of "similarity criteria" in biosimilar products. Background The draft of the concept paper was released in May 2013, and explained that EMA has received several requests in recent years regarding the adequacy of data ...
  • As Biosimilar Problems Emerge, EMA Looks to Create Quality Comparability Guideline

    The European Medicines Agency (EMA) has released a new concept paper calling for the development of a new framework to help solve one of the most difficult challenges associated with the development of biosimilar and biological products: ensuring that the quality of the biological product meets intended standards at all times during the development process. The concept paper , released on 28 June 2013, explains that EMA has received several requests in recent years rega...
  • AdvaMed Outlines Wishlist for New Changes to 510(k) Process

    The system by which most medical devices reach the market, known as the premarket notification or 510(k) process, has been subject to a considerable amount of criticism in recent years, with detractors claiming that it is both too rigorous and not rigorous enough, and legislators ordering the US Food and Drug Administration (FDA) to scrap planned changes to the process in favor of one yet to be built. Now the influential trade industry group AdvaMed, the largest medical...
  • EMA Looks to Build Framework to Allow for Less Burdensome Clinical Testing

    The European Medicines Agency (EMA) has announced the release of a new concept paper regarding the extrapolation of an experimental drug product's safety and efficacy data to other subgroups, explaining that a new guideline is needed to instruct industry on how to validate their conclusions. Background Regulators processes are an inherent balancing act between two competing forces: The need to get new therapies to patients and the need to make sure said therapies are sa...
  • Safety of Nanotechnology Focus of New EMA, MHLW Joint Reflection Paper

    The European medicines Agency (EMA) has released a new draft reflection paper on the development of nanomedicines made with block copolymer micelles (BCMs), aiming to provide basic information for the development of a common type of investigational nanomedicine. The paper is unusual in that it is being developed alongside Japan's Ministry of Health, Labour and Welfare (MHLW), the parent organization of the Pharmaceuticals and Medical Devices Agency (PMDA). Between EMA an...
  • Revisions to Osteoporosis Guideline Called for by EMA

    The European Medicines Agency (EMA) has released a new concept paper calling for revisions to the way osteoporosis products are evaluated in the EU, saying existing guidelines are largely inadequate to assess a secondary form of the disease. The problem, explained EMA, is that current osteoporosis guidelines only cover primary osteoporosis, and do not address the evaluation of products used to treat secondary osteoporosis, often brought on by glucocorticoid therapy. Gl...
  • After Failures, EMA Calls for Overhaul of Existing Obesity Treatment Guidance

    A new concept paper released by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) seeks to establish an updated framework for anti-obesity and weight control drug products. In its 1 October concept paper, " Concept paper on the need for revision of the guideline of medical products used in weight control ," CHMP looks to a November 2007 guideline on weight control, noting that two weight control products have been pulled from the marke...
  • European Regulators Want New Gout Guidelines

    The European Medicines Agency (EMA) on Thursday released a new concept paper calling for new guideline to assist sponsors conducting clinical trials on medicinal products intended to treat gout. Gout, an inflammatory arthritis brought on by the introduction of monosodium urate crystals within a patient's joints and tissues, is currently estimated to affect 3.9% of adults, with nearly three times as many men being affected as women. In its 14 June concept paper, EMA note...