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  • Regulatory NewsRegulatory News

    FDA finalizes guidance on drugs for cytomegalovirus in transplant patients

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on developing drugs to treat or prevent cytomegalovirus, a common virus in the beta-herpes virus group, in patients who have undergone solid organ (SOT) or hematopoietic stem cell transplantation (HSCT).   Cytomegalovirus, which is through to be present in 40-80% of the US population, is typically benign and self-limiting in patients with a normal immune system. However, the virus can cause compli...
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    FDA abandons proposal for devices referencing drugs

    The US Food and Drug Administration (FDA) on Thursday said it will abandon a proposed regulatory approach for medical devices referencing drugs (DRDs) that would have allowed devices to be authorized for new uses with already approved drugs when the drugmaker does not want to collaborate on the new use.   The decision comes after FDA held a public hearing to discuss the scientific, regulatory and legal challenges posed by the approach in November 2017. At the time, FDA...
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    COVID-19: FDA fights wave of fraudulent products

    As of Thursday, the US Food and Drug Administration (FDA) says it has warned 42 companies for marketing fraudulent, unproven products to treat, prevent or diagnose coronavirus disease (COVID-19).   The products include some familiar “bogus” remedies, including “miracle mineral solution,” a chlorine bleach mixture that FDA has warned against for the last decade, and colloidal silver. Other products caught up in the enforcement sweep include unapproved drugs, herbal reme...
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    CDRH explains notification requirements for device shortages under CARES Act

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday issued immediately effective guidance explaining requirements for medical device makers to notify it of shortages during the coronavirus disease (COVID-19) pandemic.   Unlike drugmakers, device makers are not typically required to report shortages or discontinuances of their products to FDA; however, the Coronavirus Aid, Relief, and Economic Security Act (CARES ...
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    CE certificates up nearly 50% in 2019 in anticipation of MDR

    In its annual sector survey, the European notified body group Team-NB found a nearly 50% uptick in the number of new CE certificates issued in 2019 as medical device makers rushed to obtain the certificates before the application of the EU Medical Device Regulation (MDR).   While the MDR is now officially delayed by one year, companies planning for the transition in 2019 were braced for the regulation to take effect later this month. (RELATED: MDR delay official as i...
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    CDER releases policy for handling newly identified safety signals

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) last week issued a new manual of policies and procedures (MAPP) explaining its internal process for identifying, evaluating and resolving newly identified safety signals (NISS) for marketed drugs.   FDA says the MAPP is meant to provide a “high level” overview of how and when communication related to newly identified safety issues is transmitted between different offices and disc...
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    FDA warns Indian testing firm, two device makers and a university lab

    In four warning letters released on Tuesday, the US Food and Drug Administration (FDA) details issues observed at an Indian contract testing laboratory, two medical device makers and a university laboratory that ran a nonclinical trial for a medical device.   Shriram Institute for Industrial Research   In its warning letter to Delhi, India-based Shriram Institute for Industrial Research, FDA cites the contract testing laboratory for repeat good manufacturing prac...
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    EMA details rapid procedures for COVID-19 products

    The European Medicines Agency (EMA) on Monday laid out its tools for expediting the development and approval of medicinal products for coronavirus disease (COVID-19), including faster scientific advice, rolling reviews and accelerated assessments.   “Supporting the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines as soon as possible is one of EMA’s top priorities in the COVID-19 public health emergency,” said EMA Dir...
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    FDA tightens oversight of antibody tests for COVID-19

    After initially allowing commercial manufacturers and laboratories to market self-validated antibody tests for coronavirus disease (COVID-19), the US Food and Drug Administration (FDA) says that commercial manufacturers must now submit an emergency use authorization (EUA) with validation data to continue marketing the tests.   Under its original policy, FDA said it would not object to the development and use of serological tests without FDA review or authorization so l...
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    FDA updates guidance on investigational use of convalescent plasma for COVID-19

    The US Food and Drug Administration (FDA) on Friday updated its recommendations for clinical investigators looking to use convalescent plasma to treat patients with coronavirus disease (COVID-19).   “Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19,” FDA writes, noting that convalescent plasma has been studied to treat other respiratory viruses, including SARS and MERS.   FDA says the updated guidan...
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    FDA authorizes Gilead’s remdesivir for emergency use

    The US Food and Drug Administration (FDA) on Friday issued an emergency use authorization (EUA) allowing the use of Gilead Sciences’ remdesivir to treat hospitalized patients with severe cases of coronavirus disease (COVID-19).   The EUA comes just two days after the National Institutes of Health (NIH) announced preliminary results from a randomized trial that found patients treated with remdesivir had a 31% shorter time to recovery than patients taking a placebo. ...
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    CHMP backs eight medicines for approval, recommends ranitidine suspension

    At its meeting earlier this week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of eight medicines, including two versions of the first triple combination asthma inhaler and two new orphan medicines.   The committee also recommended the suspension of ranitidine medicines in the EU following a review of the drugs triggered by the detection of N-nitrosodimethylamine (NDMA) impurities. The recom...