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  • Regulatory NewsRegulatory News

    FDA expands guidance on remote monitoring devices for COVID-19

    Guidance on use of non-invasive remote monitoring devices for patient care during the coronavirus public health emergency was expanded and updated by the US Food and Drug Administration (FDA) on Friday.  The guidance , originally issued in March, addresses the emergency of the coronavirus (COVID-19) pandemic by allowing modifications that “may increase access to important patient physiological data without the need for in-clinic visits,” as well as facilitating both in...
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    EMA reviewing application for Gilead’s remdesivir

    The European Medicines Agency (EMA) on Monday said it has received a conditional marketing authorization application for Gilead Sciences’ remdesivir to treat coronavirus disease (COVID-19) that could receive an opinion in a matter of weeks.   “The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks depending on the robustness of the data submitted and whether further information is r...
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    E-signatures clarified in FDA’s COVID-19 clinical trial guidance

    The US Food and Drug Administration (FDA) updated its guidance regarding informed consent for clinical trials during the coronavirus public health emergency to add information about electronic signatures for informed consent, and to provide clarification about remote assessments during clinical trials.   In its announcement regarding the updates, FDA said that it issued the guidance “because we recognize that the COVID-19 public health emergency may impact the conduc...
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    FDA defends its oversight of foreign drugs amid Senate, GAO criticism

    During a Senate Committee on Finance hearing Tuesday, officials from the US Food and Drug Administration (FDA) responded to criticism from senators and a new report from the Government Accountability Office (GAO) on its oversight of foreign drug manufacturers.   The hearing follows FDA’s move to halt most foreign inspections in March as a result of the coronavirus disease (COVID-19) pandemic. (RELATED: Coronavirus prompts FDA to cancel travel, postpone inspection...
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    FDA eases IRB review of COVID-19 expanded access requests

    Institutional review boards (IRBs) may establish procedures to have a single IRB member review individual patient expanded access requests for investigational drugs and biologic products to treat coronavirus disease (COVID-19), says new guidance from the US Food and Drug Administration (FDA).   The guidance provides clarification for IRBs that may be seeing increased numbers of individual patient expanded access requests related to COVID-19 infection.   In light ...
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    FDA’s MyStudies app provides platform for electronic informed consent

    An app developed by the US Food and Drug Administration (FDA) provides a way to obtain informed consent for clinical trials in a format easily accessed by both investigators and participants.   The app, FDA MyStudies, can now be found as COVID MyStudies in both the Google Play and Apple App stores. In addition to providing a mechanism for securing informed consent from prospective clinical trial participants, the app also gives investigators the option to incorporat...
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    Hahn: FDA will make some changes amid COVID-19 permanent

    The US Food and Drug Administration (FDA) will look to permanently implement some of the processes and policies adopted in its response to the coronavirus disease (COVID-19) pandemic, FDA Commissioner Stephen Hahn said during a virtual briefing hosted by the Alliance for a Stronger FDA on Monday.   Hahn’s statements during the briefing closely mirrored statements he made in a pre-recorded video FDA uploaded to YouTube on Friday.   “As this pandemic has evolved, i...
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    EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

    In a response to officials at Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration, European Medicines Agency (EMA) Executive Director Guido Rasi said the agency is trying to figure out how to be transparent with regard to clinical trial data for products it reviews to treat or prevent coronavirus disease (COVID-19).   After spending years implanting its policy for proactively publishing clinical data for products submitt...
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    CHMP backs eight new medicines, waiting on remdesivir application

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending the authorization of eight new medicines, including a new vaccine against Ebola virus, and says it is waiting for Gilead Sciences to submit an application for conditional marketing authorization for remdesivir to treat coronavirus disease (COVID-19).   The update on the status of remdesivir comes nearly a month after the committee began a rolling review of the dr...
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    FDA releases EUA template for COVID-19 home sample collection kits

    The US Food and Drug Administration (FDA) on Friday released a new emergency use authorization (EUA) template to assist test makers in developing at-home sample collection kits for use with tests for coronavirus disease (COVID-19).   The new template comes after FDA authorized several tests and a standalone sample collection kit for at-home sample collection from testing companies including LabCorp, Quest Diagnostics, Everlywell and PrivaPath Diagnostics. (RELATED: F...
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    EMA explains GMP and GDP flexibilities amid COVID-19

    The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP).   (RELATED: EMA Q&A explains regulatory expectations for drugs during the...
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    Health Canada releases guidance to streamline COVID-19 clinical trials

    Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.   The guidance documents support an interim order (IO) that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate or diagnose COVID-19.   The IO has dropped administrative requirements for non-significant changes during a...