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  • Regulatory NewsRegulatory News

    FDA yanks EUA for serology test

    The US Food and Drug Administration (FDA) on Tuesday revoked the emergency use authorization (EUA) granted to Chembio Diagnostic Systems Inc. for its DPP COVID-19 IgM/IgG System based on several sets of data indicating that the test generates false results at a higher rate than expected. This is the first revocation of an EUA for a SARS-CoV-2 serology test during the COVID-19 public health emergency. The system in question is an antibody test for the novel coronavirus; ...
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    FDA warns of potential drug interaction with remdesivir

    Hours after revoking its emergency use authorization (EUA) for hydroxychloroquine and chloroquine to treat coronavirus disease (COVID-19), the US Food and Drug Administration (FDA) is now warning that the drugs could interact with Gilead Sciences’ remdesivir, potentially reducing its antiviral activity.   Remdesivir, also authorized under an EUA, is now the only drug with emergency authorization to treat COVID-19 in the US. (RELATED: FDA revokes EUA for hydroxychlo...
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    FDA revokes EUA for hydroxychloroquine, chloroquine

    The US Food and Drug Administration (FDA) on Monday revoked the emergency use authorization (EUA) allowing the use of chloroquine phosphate and hydroxychloroquine sulfate to treat hospitalized patients with coronavirus disease (COVID-19) at the request of the Biomedical Advanced Research and Development Authority (BARDA).   “Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may n...
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    UPDATED: FDA’s CURE ID app gets COVID-19 refresh

    This article, originally published 10 June, was updated 12 June to include commentary from an FDA spokesperson. An online case reporting platform has been optimized for COVID-19 and will be the springboard for a new public-private drug repurposing collaboration.   The CURE ID online platform was developed to allow clinicians to report off-label uses of drugs to treat infectious diseases, with the goal of generating hypotheses for further study of difficult-to-tr...
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    EMA management board backs rolling review fees, COVID-19 transparency measures

    After its June meeting on Thursday, the European Medicines Agency’s (EMA) management board said it has approved a new fee for rolling reviews and that the agency will be providing more details about its approach to publishing clinical data for vaccines and drugs for coronavirus disease (COVID-19).   The new rolling review fee “would be deducted from the fee that would become due with the submission of an actual marketing authorisation application.” The specific fee a...
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    BIO: FDA weighs post-pandemic challenges

    Pharmaceutical companies and officials at the US Food and Drug Administration are working with unprecedented speed and creativity during the coronavirus pandemic. But there’s little reason to think the workload will abate, or the problems become easier, in the post-pandemic lives of sponsors and regulators, according to panelists who spoke during an FDA Town Hall at the Digital BIO 2020 meeting. Even amid the pandemic, not all of FDA’s work is centered on COVID-19 vac...
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    FDA grants first EUA for COVID next-generation sequencing

    The US Food and Drug Administration (FDA) has issued the first emergency use authorization to Illumina for a sequencing-based in vitro diagnostic test to detect SARS-CoV-2, the virus that causes COVID-19.   “Having a next generation sequencing diagnostic tool available will continue to expand our testing capabilities. Additionally, genetic sequencing information will help us monitor if and how the virus mutates, which will be crucial to our efforts to continue to lea...
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    EMA issues guidance on remote GCP inspections

    The European Medicines Agency (EMA) on Wednesday posted new guidance explaining how remote good clinical practice (GCP) inspections should be conducted amid the coronavirus disease (COVID-19) pandemic.   EMA says that GCP inspections are “indispensable” to its assessment of marketing authorization applications, especially during a public health crisis. European authorities have previously provided guidance on good manufacturing practice (GMP) certificates allowing for ...
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    EMA affirms ACE inhibitors, ARBs safe during COVID-19

    The European Medicines Agency (EMA) has issued a statement reiterating that people should continue to take certain blood pressure medicines during the COVID-19 pandemic. Recent observational studies, the agency said , have not shown that taking angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) increases the risk of contracting the novel coronavirus or worsening illness for people with COVID-19. The statement reaffirms EMA’s previous...
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    Marks dishes on COVID-19 vaccine development at BIO

    Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) told a panel at BIO Digital he thinks global regulators will be aligned on the clinical endpoints and design features of Phase 2 and 3 clinical trials for vaccines to prevent coronavirus disease (COVID-19).   Marks also emphasized that FDA is working closely with its colleagues around the world to expedite the development and availability of safe and...
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    Cell and gene therapies: FDA official on COVID-19 impact

    Speaking at a session on cell and gene therapies at BIO Digital on Monday, a top US Food and Drug Administration (FDA) official discussed the impact of the coronavirus disease (COVID-19) pandemic on the agency’s work related to cell and gene therapies.   “Before the pandemic, we were seeing a huge escalation in the workload that we have to make adjustments for,” said Wilson Bryan, director of the Office of Tissues and Advanced Therapies at the Center for Biologics Eval...
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    Drug samples: FDA issues policy on distribution amid COVID-19

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance explaining the agency’s enforcement of drug sample distribution requirements during the coronavirus disease (COVID-19) public health emergency.   The Prescription Drug Marketing Act of 1987 (PDMA) and its implementing regulations found in 21 CFR part 203 set out requirements for the distribution of prescription drugs by mail or common carrier, including requirements for sto...