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  • Regulatory NewsRegulatory News

    How to assess symptoms in COVID-19 trials: new FDA guidance

    Investigators should use a patient-reported outcomes approach, with an emphasis on electronic data collection, in their research on therapies to treat or prevent COVID-19, according to a new guidance from the US Food and Drug Administration (FDA). The guidance, which is effective immediately during the public health emergency of the coronavirus pandemic, outlines how to capture disease-related symptoms in clinical trials focusing on COVID-19 prevention or treatment for ...
  • RoundupsRoundups

    FDA Approvals Roundup: Detectnet, Nityr, Trelegy Ellipta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Detectnet okayed for locating neuroendocrine tumors during PET RadioMedix’s Detectnet (copper Cu 64 dotatate injection) has been approved for the detection of somatostatin receptor‒positive neuroendocrine tumors (NETs) in adult patients during imaging with positron emission tomography.   Approval for the radioactive diagnostic agent was sup...
  • Regulatory NewsRegulatory News

    EMA to require clinical data publication for COVID-19 related products

    The European Medicines Agency (EMA) this week announced it will require drugmakers to publish clinical data for medicines and vaccines authorized to treat or prevent coronavirus disease (COVID-19) as part of its exceptional transparency measures during the pandemic.   After spending years implanting its policy for proactively publishing clinical data for products submitted to the agency for review, EMA suspended the publication requirement in August 2018 to focus on ...
  • Regulatory NewsRegulatory News

    FDA shares comparative performance data for COVID-19 tests

    The US Food and Drug Administration (FDA) on Tuesday released comparative performance data for 58 coronavirus disease (COVID-19) molecular diagnostics being used under emergency use authorizations (EUAs).   Specifically, FDA has published limit of detection (LoD) data for the tests against a standardized panel it developed and began distributing to test developers in May. FDA says it has so far contacted the developers of 176 authorized tests and has provided reference...
  • Regulatory NewsRegulatory News

    Medical cannabis regulation is a global patchwork

    (Editor's note: this article was updated to clarify which products made from cannabis or hemp plants fall under Health Canada's Natural Health Products category.) The framework for regulating cannabis as a pharmaceutical product varies widely across the world, though increased clinical research into cannabis products means more approvals are likely under any scenario.   “It’s currently a complex patchwork of approaches,” Michael Craig, a principal consultant at Pa...
  • ReconRecon

    Recon: US COVID vaccine distribution plans; EU plans new biomedical research agency

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US plans to distribute COVID-19 vaccine immediately after regulators authorize it ( Reuters ) ( Politico ) Trump says coronavirus vaccine could be weeks away ( Reuters ) HHS chief overrode FDA officials to ease testing rules ( Politico ) US FDA's Hahn plans 'significant' work with AstraZeneca in COVID-19 trial inquiry ( Reuters ) Pfizer says late-stage corona...
  • Regulatory NewsRegulatory News

    CDRH updates at Convergence: COVID-19 and ISO 13485

    Top officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) responded to questions raised during the CDRH Forum at RAPS Convergence 2020 on Tuesday.   COVID-19   Opening the forum, CDRH Director Jeff Shuren said that one of CDRH’s priorities will be to determine how it can carry forward some of the flexibilities it has embraced during the coronavirus disease (COVID-19) pandemic.   “The greatest tragedy of the...
  • Regulatory NewsRegulatory News

    FDA warns Sprout for misleading Addyi come-on

    Sprout Pharmaceuticals’ promotion of Addyi both mischaracterizes the drug’s indication and downplays potential serious adverse events associated with its use, according to a warning letter from the US Food and Drug Administration (FDA).   Sprout Pharmaceuticals markets the non-hormonal drug Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. To meet HSDD criteria, low desire must cause marked distress or i...
  • Regulatory NewsRegulatory News

    How to build a professional brand in a virtual world

    CEOs are not the only people who need to worry about their professional branding, attendees of RAPS Convergence 2020 heard during a plenary session. All regulatory professionals should establish a professional brand online and take the time to maintain it.   “How you are perceived is how you succeed,” said Elena Kyria during the 15 September plenary session.   What is a professional brand? It is your professional reputation and it precedes you, surrounds you, and f...
  • ReconRecon

    Recon: AstraZeneca resumes COVID vaccine trials in South Africa, Brazil, US study still on hold

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump says not pressing US government for coronavirus vaccine for political reasons ( Reuters ) AstraZeneca COVID-19 vaccine trial in US on hold until at least midweek – sources ( Reuters ) ( KHN ) Bill Gates Wonders Whether FDA Can Be Trusted on a Covid Vaccine ( Bloomberg ) Axios-Ipsos poll: Distrusting Big Pharma and the FDA ( Axios ) Compass Pathways set ...
  • RoundupsRoundups

    Asia-Pacific Roundup: Australia to permit some self-test IVDs after industry calls for change

    The Therapeutic Goods Administration (TGA) is set to allow the sale of a limited range of self-test in vitro diagnostics (IVDs) in Australia. TGA proposed the regulatory change after GlaxoSmithKline and other organizations used a consultation to voice their dissatisfaction with the current system.   Home-use tests for serious diseases have been banned in Australia for the past decade. TGA made an exception for HIV tests in 2014 but has otherwise maintained the position...
  • Regulatory NewsRegulatory News

    MDR/IVDR update: Experts share what keeps them up at night

    Speaking virtually at RAPS Convergence on Monday, top European medical device and in vitro diagnostic (IVD) experts shared what keeps them up at night as the date of application for both the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) approach.   With MDR delayed to May 2021, and with Eudamed’s full rollout and the IVDR date of application seemingly on track for May 2022, regulators, industry and notified bodies have much to prepare...