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  • 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...
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    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...
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    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...
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    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 ...
  • ReconRecon

    Recon: US trials blood thinners in COVID patients; Pharma’s campaign against ICER

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Marks: Prepare for 'EUA-plus' for Covid vaccines ( Politico ) ( Pink Sheet ) FDA chief says he has ‘no intention’ of overruling career staff on coronavirus vaccine decision ( CNBC ) Covid vaccine becomes divisive issue in US election campaign ( FT ) FDA Regulators Publish Rare Self-Defense Amid Rising Vaccine Pressure ( NYTimes ) Big Pharma wages stealth war ...
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    Wide swath of online opioid sellers warned by FDA

    Seventeen website operators recently received warning letters from the US Food and Drug Administration (FDA) for selling unapproved and misbranded opioids. The letters were issued on 31 August 2020 to operators of websites based in China, Iceland, India, New Zealand, Pakistan and the United States.   Operators of the websites, which carry names such as “www.buydrugsmedsonline.com” and “www.beststeroidstore.net,” were warned for offering opioids such as oxycodone and tr...
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    FDA calls for stakeholders to join GDUFA talks

    The US Food and Drug Administration (FDA) this week called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Generic Drug User Fee Amendments (GDUFA III) program.   The call comes less than two months after the agency held its GDUFA III reauthorization kickoff meeting, during which industry stakeholders sought improvements to the generic...
  • ReconRecon

    Recon: FDA approves GSK's three-drug asthma inhaler; EMA extends review of BioMarin gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senior FDA career executives: We're following the science to protect public health in pandemic ( USA Today ) The coronavirus pandemic underscores the need to bring drug manufacturing back to US ( CNBC ) Several Covid-19 Vaccines Could Join Winner’s Circle ( WSJ ) GSK's three-drug inhaler wins US nod for use in asthma patients ( Reuters ) ( Endpoints ) Trump s...
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    RAPS' LatestRAPS' Latest

    RAPS recognizes new Fellows, Creaven-Capasso, Drago and McKeen

    RAPS has announced the three outstanding senior regulatory professionals comprising the 2020 class of RAPS Fellows . The honor of being a RAPS Fellow is reserved for seasoned, proven leaders, who thrive on building and sharing regulatory knowledge that shapes the future of the profession. New Fellows are selected annually and recognized in conjunction with RAPS Convergence , the largest annual conference for the global healthcare regulatory community. This year’s event w...
  • RoundupsRoundups

    Euro Roundup: EU vows to hold COVID vaccine firms liable for side effects

    Developers of COVID-19 vaccines used in the European Union will be legally liable in the event of hidden defects or other problems with their products, a senior official at the Directorate-General for Health and Food Safety (DG SANTE) has vowed.   Last month, Reuters reported that differing opinions over the level of legal protection that should be afforded to developers of COVID-19 vaccines were hampering efforts to strike deals for the products needed to protect ...