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  • RoundupsRoundups

    EU Regulatory Roundup: Neuropsychiatric disorders prompt safety probe of hydroxychloroquine

    Cases of neuropsychiatric disorders in Spanish patients taking hydroxychloroquine for the treatment of COVID-19 have triggered a Europe-level review of the safety of the treatment.   Concerns about the risks posed by administering hydroxychloroquine to COVID-19 patients have so far primarily focused on the link between the drug and cardiac arrhythmia. However, the history of use of hydroxychloroquine in the treatment of conditions including lupus and malaria shows the ...
  • Regulatory NewsRegulatory News

    FDA names companies removed from antibody test list

    After tightening its oversight of antibody tests for coronavirus disease (COVID-19) earlier this month, the US Food and Drug Administration (FDA) on Thursday began publicly listing commercial manufacturers that have either failed to submit an emergency use authorization (EUA) request or voluntarily withdrew notification for their antibody tests distributed under the agency’s former policy.   In its initial policy in March, FDA said it would not object to the developmen...
  • ReconRecon

    Recon: US secures 300M doses of potential AZ-Oxford vaccine; Beximco launches generic remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US gives up to $1.2 billion to AstraZeneca for Covid-19 vaccine ( STAT ) ( Reuters ) ( FT ) Trump’s Vaccine Chief Has Vast Ties to Drug Industry, Posing Possible Conflicts ( NYTimes ) Biosimilars got the cold shoulder from health plans when it came to preferred coverage ( STAT ) GSK ties up with gene editing start-up Mammoth for COVID-19 test ( Reuters ) High...
  • Regulatory NewsRegulatory News

    EC eases rules for renewing notified body designations, explains process for EU-wide derogations

    The European Commission has issued new regulations easing the process for renewing notified body designations prior to the new date of application for the Medical Devices Regulations (MDR), 26 May 2021.   The move comes as the Commission works to realign the various components of its regulatory framework for medical devices to accommodate the one-year MDR delay necessitated by the coronavirus disease (COVID-19) pandemic and the two-year Eudamed delay announced last y...
  • Epinephrine and morphine added to FDA’s COVID-19 compounding lists

    Two more injectable medications have been added to the US Food and Drug Administration’s (FDA) guidances on drugs that can be compounded by registered outsourcing facilities and some smaller compounders if they are used for patients hospitalized with the novel coronavirus COVID-19.   The addition of epinephrine and morphine sulfate to the guidances brings the total number of drugs listed to 15. Most of the medications are anesthetics or analgesics that support mechanic...
  • Regulatory NewsRegulatory News

    EMA extends virtual-only meeting policy through August

    The European Medicines Agency (EMA) on Tuesday announced it is extending its decision to hold all upcoming meetings virtually through August 2020 as a safety measure amid the ongoing coronavirus disease (COVID-19) pandemic.   EMA first made the shift to virtual-only meetings because of COVID-19 in March and extended the policy in April to continue through the end of May. Since mid-March, most EMA staff have worked remotely as well. (RELATED: Coronavirus: WHO declares...
  • Regulatory NewsRegulatory News

    FDA warns bronchoscope manufacturer for complaint handling, validation issues

    The manufacturer of a rigid bronchoscope system received a warning letter last month from the US Food and Drug Administration (FDA) for lack of adequate evaluation of complaints that components of the system separated during procedures, together with other deficiencies.   Massachusetts-based Lymol Medical Corporation (Lymol) manufactures the Medical Elite X Class Rigid Bronchoscope System and the Lymol Medical Optical Telescope. The FDA warning letter of 7 April 2020...
  • ReconRecon

    Recon: Woodcock, Marks recuse themselves from COVID-19 vaccine approval decisions; FDA approves Lynparza for prostate cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amid conflict-of-interest criticisms, top FDA officials recuse themselves from Covid-19 vaccine approvals ( STAT ) Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine ( STAT ) Prototype Vaccines Protect Monkeys From Coronavirus ( NYTimes ) ( Reuters ) Inovio says COVID-19 vaccine produces antibodies in mice, guinea pigs ( Reu...
  • Regulatory NewsRegulatory News

    FDA, Aetion partner on real-world data analytics for COVID-19

    The US Food and Drug Administration (FDA) on Tuesday said it will partner with New York-based health technology firm Aetion, Inc. to develop real-world data analytics to answer pressing questions related to coronavirus disease (COVID-19).   “Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity and understand available medical product supplies to help mit...
  • Regulatory NewsRegulatory News

    FDA warns contract testing laboratory for CGMP deviations

    The US Food and Drug Administration (FDA) last month issued a warning letter to New Jersey-based contract testing laboratory International Trading Pharmaceutical Laboratories (ITPL) over significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).   During a two-week inspection in October 2019, FDA found that ITPL’s Quality Unit had not acted on findings of an out-of-specification (OOS) investigation; chromatograph...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA orders re-evaluation of COVID-19 antibody studies amid false negative concerns

    Australia’s Therapeutic Goods Administration (TGA) has asked the sponsors of point-of-care tests for antibodies against the SARS-CoV-2 coronavirus to re-evaluate their clinical performance studies. TGA made the request after reviewing the findings of a postmarket evaluation carried out by a third party.   The Onsite and VivaDiag tests, which are made by CTK Biotech and VivaChek Biotech, respectively, came to market with instructions for use that quoted sensitivity figu...
  • ReconRecon

    Recon: BARDA awards new firm $350M for domestic drug production; FDA approves Tecentric for first-line therapy for some lung cancers

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump says big announcements made and coming on therapeutics, vaccines ( Reuters ) Trump to Tap New Company to Make Covid-19 Drugs in the US ( NYTimes ) ( Reuters ) Politics could dictate who gets a coronavirus vaccine ( Politico ) Trump says he is taking hydroxychloroquine despite FDA warning ( Reuters ) CDC plans sweeping COVID-19 antibody study in 25 metro...