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  • 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 ...
  • Regulatory NewsRegulatory News

    Voluntary consensus standards guidance updated by FDA

    Voluntary consensus standards guidance updated by FDA   The US Food and Drug Administration has issued a final guidance addressing voluntary consensus standards, updating a September 2018 version.   The final guidance also supersedes one issued in 2007 by the Center for Devices and Radiological Health (CDRH) entitled “CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition.”   The final document, ...
  • Regulatory NewsRegulatory News

    FDA updates Pre-Cert pilot for SaMD

    Lessons learned from a digital health software pilot pre-certification program have readied the US Food and Drug Administration (FDA) to test an updated version of the continuous evaluation program for developers of software as a medical device (SaMD).   The precertification (Pre-Cert) pilot “will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices,” said FDA in...
  • ReconRecon

    Recon: Gilead to buy Immunomedics for $21B; Trump signs international reference pricing order

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump unveils plan to slash drug costs tied to what's paid abroad ( Politico ) ( NYTimes ) ( WSJ ) ( STAT ) Trump Pressed for Plasma Therapy. Officials Worry, Is an Unvetted Vaccine Next? ( NYTimes ) Gilead Reaches Deal to Buy Immunomedics for $21 Billion ( WSJ ) ( FT ) ( Reuters ) ( STAT ) Merck to buy $1 bln stake in Seattle Genetics, co-develop cancer thera...
  • Regulatory NewsRegulatory News

    Embracing disruption: Convergence plenary stresses compassion, innovation

    The COVID-19 pandemic has turned daily life upside down around the globe and presented unique challenges for regulatory affairs professionals. In the kickoff plenary session of RAPS 2020 Convergence, regulatory experts and business leaders shared how they have coped with the unprecedented disruption and offered insights about how the pandemic may be accelerating industry-wide changes. The conversations were facilitated by Kimberly Belsky, vice chair for Convergence and ...
  • Regulatory NewsRegulatory News

    Pharmacists can give COVID-19 vaccines, says HHS

    The US Department of Health and Human Services has authorized all state-licensed pharmacists and pharmacy interns who have completed required training to administer vaccines for COVID-19 when they become available.   The new guidance , dated 3 September 2020, supersedes any state or local laws that “prohibit or effectively prohibits” pharmacists and interns who would otherwise be able to perform vaccination under the new HHS directive.   However, the guidance sets...