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  • Regulatory NewsRegulatory News

    FDA’s first patient-focused drug development guidance now final

    Final guidance for drugmakers on gathering comprehensive and representative input from patients is now available from the US Food and Drug Administration (FDA).   The document is the first in a series of four that will outline patient-focused drug development (PFDD) guidance “to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information fr...
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    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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    BIO: What it takes to make the leap to decentralized trials

    Though there’s excitement and much promise in leveraging technology to meet participants on home turf, “We’re all still taking baby steps in bringing the clinical trial to the patient,” said Rasika Kalamegham, speaking of making the move to decentralized clinical trials. Moderating a decentralized trial-focused session at BIO Digital, she and other session participants discussed how to tease out where promise lies and what hurdles stand in the way of sponsors, regulators, ...
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    Regulators discuss accelerated approvals, Project Orbis at DIA

    Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada gave their perspectives on different issues related to accelerated approval pathways in their respective jurisdictions at the DIA Global Annual Meeting.   All three regulators offer their own form of accelerated approval based on less comprehensive clinical data than a traditional marketing approval would require. In the US, that pathway is dubbed accelerated ap...
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    Four homeopathic injectable producers warned by FDA

    The US Food and Drug Administration (FDA) issued warning letters to four companies marketing unapproved homeopathic injectable drugs on Tuesday, noting specific concerns about the potential for public harm from their products.   “The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses. These unapproved injectable drugs are particularly concerning because they inhere...
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    FDA warns Takeda over aseptic processing, inadequate investigations

    The US Food and Drug Administration (FDA) last week warned Japanese drugmaker Takeda Pharmaceutical over good manufacturing practice (GMP) violations observed during an inspection of its Hikari, Yamaguchi facility last November.   Specifically, the warning letter cites the firm for three violations relating to its procedures for aseptic manufacturing and investigations into unexplained discrepancies and equipment malfunctions.   “Our inspection found that your Qual...
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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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    No COVID claims for exosome product, warns FDA

    A firm that manufactures human stem cell and exosome products was cited by the US Food and Drug Administration (FDA) for marketing an exosome product to treat or prevent the novel coronavirus, COVID-19 without premarket review or approval.   In the warning letter dated June 4, FDA quoted EUCYT Laboratories’ website, which claimed that “COVIXO drives cellular functionality including augmenting the type 1 interferon pathway ... that is important for anti-SARS-CoV-2 act...
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    First video game-based treatment gets go ahead from FDA

    A milestone for digital therapeutics was reached Monday with the US Food and Drug Administration’s (FDA) decision to grant a de novo request for Akili Interactive’s video game-based EndeavorRX to treat attention deficit hyperactivity disorder (ADHD).   FDA says the device is the “first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorization by the FDA for any type of conditio...
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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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    FDA addresses ANDA conversion to tentative approval for patent infringement

    A new Manual of Policies and Procedures (MAPP) from the US Food and Drug Administration (FDA) addresses conversion of an abbreviated new drug application’s (ANDA) status from final to tentative approval following a court order for patent infringement.   The MAPP from the Office of Generic Drugs (OGD) describes policies and procedures for converting an abbreviated new drug application (ANDA) from final approval to tentative approval when a court order for patent infri...
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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...