RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    FDA reports more shortages of drugs used to put COVID-19 patients on ventilators

    Increasing demand for sedatives used to help put COVID-19 patients onto ventilators means the US Food and Drug Administration (FDA) added two more – this time the injectables propofol and dexmedetomidine – to its list of drug shortages. The propofol shortage was also previously listed by the American Society for Health-System Pharmacists (ASHP) earlier this month, with manufacturers noting increased demand. Michael Ganio, senior director of pharmacy practice and quali...
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    FDA offers guidance for generic drug developers of hydroxychloroquine, chloroquine

    The US Food and Drug Administration (FDA) on Monday issued two new product-specific guidance documents for the unproven but highly demanded potential COVID-19 drugs chloroquine phosphate and hydroxychloroquine sulfate. The two generic drugs, approved by FDA as malaria drugs, have been touted by President Donald Trump in press conferences during the pandemic, but clinical trial data regarding their efficacy for COVID-19 remain thin. Regardless, 30 million doses of hyd...
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    EMA Q&A explains regulatory expectations for drugs during the pandemic

    The European Medicines Agency (EMA) and European Commission on Friday released a question and answer document on regulatory expectations for marketing authorization holders (MAHs) and medicines during the COVID-19 pandemic. The Q&A discusses issues related to marketing authorizations, manufacturing and imports, quality variations, product information and labeling. As far as marketing a medicine in the absence of an authorization, the Q&A says that member states can r...
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    FDA issues 2nd EUA for decontamination system for N95 masks

    The US Food and Drug Administration on Friday issued a second emergency use authorization (EUA) to help decontaminate N95 or N95-equivalent respirator masks so they can be reused by health care workers in hospitals. FDA said this EUA, issued to Steris Corporation for a system that uses vaporized hydrogen peroxide, will support the decontamination of about 750,000 N95 respirators per day in the US. The EUA comes as shortages of the masks have pushed some hospitals to...
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    FDA, EC offer guidance on COVID-19 convalescent plasma

    The US Food and Drug Administration (FDA) and European Commission (EC) recently released guidance on convalescent plasma collected from individuals who have recovered from COVID-19 and which may potentially be used as a treatment for COVID-19. FDA’s 9-page guidance, which follows the agency’s granting of the use of single patient emergency Investigational New Drug Applications (eINDs) to the investigational plasma, is meant to provide recommendations to health care pr...
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    Regulators urge RCTs with control arms for COVID-19 drug trials

    As no specific therapeutic has clearly demonstrated efficacy for treating COVID-19, more than two dozen pharmaceutical regulators around the world agreed in a virtual workshop last week that randomized controlled trials (RCTs), long considered the gold standard for clinical trials, will be necessary for approvals. The summary report of the meeting also stressed the need for COVID-19 drug developers to include an appropriate control arm (“i.e. not including antivirals or...
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    MDCG explains when devices can be exempt from premarket clinical consultations

    The Medical Device Coordination Group (MDCG) recently updated its guidance on interpreting Article 54(2)b of the Medical Devices Regulation (MDR), which discusses the criteria that exempt devices from the premarket clinical evaluation consultation procedure with expert panels. According to the text of the article, the clinical evaluation consultation procedure shall not been required when: (a) a firm is renewing certificate under MDR; (b) a device “has been design...
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    Notified body audits during the pandemic: New MDCG guidance

    The Medical Device Coordination Group (MDCG) on Wednesday issued guidance to help notified bodies perform audits during the pandemic, including, under certain circumstances, remote audits. The 5-page guidance deals strictly with surveillance audits under the medical devices directives, audits conducted for recertification purposes under the directives, in cases where a manufacturer submits a change notification to a notified body that would typically require an on-site ...
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    EC offers antitrust reassurances to generic drugmakers cooperating on shortages

    The European Commission on Wednesday reassured the generic drug association Medicines for Europe that member and nonmember companies can work together to battle shortages of critical hospital drugs to treat COVID-19 patients. The commission explains how generic firms may need to coordinate on stock management and distribution “so that not all undertakings focus on one or a few medicines, while others remain in under-production. Such coordination would be contrary to ant...
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    Compounding drugs during the pandemic: FDA offers policy clarifications

    In response to “many emails from stakeholders,” the US Food and Drug Administration (FDA) late Monday clarified a few policies related to drug compounding, including one on the limit on the interstate distribution of compounded drug products for pharmacy compounders. Overall, FDA said its policies are meant to protect patients from unsafe, ineffective and poor-quality compounded drugs while preserving access for patients. In one of the updates, FDA clarifies that a ...
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    IMDRF consultations focus on IVD classifications, regulatory assessors

    The International Medical Device Regulators Forum (IMDRF) recently released two consultations for comment on classifying in vitro diagnostics (IVDs) and improving the efficiency and ensuring regulators appropriately conduc assessments of Conformity Assessment Bodies (CABs). The 16-page proposed document on IVD classification is meant to help IVD manufacturers select an appropriate risk class using a set of harmonized classification principles and based on the device’s...
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    New system to speed industry-EMA interactions on drug shortages

    The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is currently establishing, with the pharmaceutical industry, the i-SPOC (industry single point of contact) system to speed up interactions on drug shortages between industry and the steering group, the European Medicines Agency (EMA) said Monday. Although medicine shortages are dealt with at the national level in the EU by national competent authorities, under this new system each pharmaceu...