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  • 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 ...
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    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...
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    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...
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    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, ...
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    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 ...
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    Regulatory obligations beyond the new MDR deadline: A long-term focus

    Even with the EU MDR transition deadline being pushed back one year until May 2021, the deadline is still fast approaching. Many organizations were stretched thin in their attempt to meet the changes to the vast number of Standards and regulations for the original deadline. While achieving compliance before the new deadline is essential, many companies within the medical device (MedDev) industry may find themselves in trouble in the months following. Staying focused on t...
  • 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...
  • Regulatory NewsRegulatory News

    Drugmakers get return-to-normal guidance from FDA

    A new temporary guidance for drug and biologics manufacturers from the US Food and Drug Administration (FDA) details recommendations for returning to normal production operations during the public health emergency of the COVID-19 pandemic.   “This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduce...
  • Regulatory NewsRegulatory News

    Marks, Hahn confirm COVID vaccine EUA guidance coming

    The US Food and Drug Administration (FDA) will soon issue guidance on the data needed to support an emergency use authorization (EUA) for a vaccine to prevent coronavirus disease (COVID-19) according to Center for Biologics Evaluation and Research (CBER) Director Peter Marks.   Speaking at an event hosted by the Duke Margolis Center for Health Policy on Thursday, Marks hinted that additional guidance on EUAs for COVID-19 vaccines would be coming soon.   “You may ...