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  • Feature ArticlesFeature Articles

    Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy

    This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical...
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    Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers

    This article summarizes FDA enforcement policy during the early months of the COVID-19 public health emergency and outlines the regulatory considerations for temporary enforcement discretions. The authors emphasize the importance of routine and scientific communication between the FDA, industry, and providers to facilitate the long-term directions of these technologies.   Introduction Historically, the US Food and Drug Administration (FDA) has played an important rol...
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    Update on trade issues affecting the dietary supplement industry

    This article discusses recent updates on US trade policy issues in the dietary supplement industry. It focuses on the trading relationship between the US and its largest trading partners, including China, and analyzes the ongoing effects of current trade policies on companies that produce, buy, and sell dietary supplements. The authors discuss tools available to US companies to reduce financial liability when trade policies are evolving at a rapid pace.   Introduction ...
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    Gottlieb Testifies on Status of FDA Operations After Government Shutdown

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb testified before the House Committee on Appropriations Wednesday on the current state of agency activities. Gottlieb expressed confidence that the agency is “back on track,” despite the 35-day lapse in FDA appropriations during the longest partial government shutdown in US history. Members of the subcommittee on agriculture, rural development, FDA and related agencies questioned Gottlieb on the status of ...
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    FDA Adds Unpaid Exceptions as the Shutdown Drags On

    As the shutdown continues in its third full week, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb took to Twitter on Sunday to reveal additional activities that are considered “excepted, unpaid work” because they are necessary to identify and respond to threats to human safety. The additional activities, which have been added after careful analysis and in close consultation with senior FDA leaders and public health experts, include: Expanded inspect...
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    GAO Calls on FDA to Evaluate its Efforts on Least Burdensome Approach for Devices

    The Government Accountability Office (GAO) has told the US Food and Drug Administration (FDA) to develop metrics to evaluate its performance in implementing its least burdensome approach to regulating medical devices, according to a report released on Tuesday. Congress first required FDA to implement a least burdensome approach for reviewing 510(k) and premarket application (PMA) submissions in the 1997 Food and Drug Administration Modernization Act (FDAMA) . Since then...
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    New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety

    A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms. The study, conducted by researchers at Harvard Medical School, Northeastern University, Boston Children's Hospital and The Ohio State University, and funded by FDA's Center for Drug Evaluation and Research, looks specifica...
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    FDA Begins Adding Suffixes to Newly Approved Biologics' Names

    • 17 November 2017
    The US Food and Drug Administration (FDA) this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in policy from only adding the suffixes to biosimilars' nonproprietary names since 2015. The first additions of the meaningless suffixes came for Thursday's approval of Roche's Hemlibra (emicizumab-kxwh), one of the first new medicines in nearly two decades to treat people with hemophilia A, ...
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    FDA Enforcement Trends for Broadcast Advertisements

    This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information. Introduction From January 2016 through Augus...
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    GAO: FDA Needs a Plan for GDUFA Carryover Fees

    As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers. "Such a documented plan could aid Congress in determining the appropriate amount of user fees to be collected by the agency during the annual appropriations process and when considering a reauthorization of th...
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    Gottlieb Establishes FDA Committee to Confront Opioid Crisis

    Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction." As a first step, Gottlieb announced the establishment of an Opioid Policy Steering Committee to bring together some of the agency’s senior career leaders to explore and develop tools or strategies to confront the crisis. The initial quest...
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    Generic Drug Industry Group Seeks FDA Regulation Changes

    The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce. In addition to citing a lack of clarity in the regulations governing the permitting processes of large life sciences projects, David Gaugh, SVP for sciences and regulatory affairs at AAM, called for five actions to reduce the regulatory bu...