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  • Regulatory NewsRegulatory News

    Convergence: Global planning is key to successful development of companion diagnostics

    Planning and alignment are the keys to successfully steering companion diagnostics through regulatory processes across the globe, according to experts who spoke at RAPS Convergence 2020.   “The most critical way to develop a companion diagnostic is really a coordinated, co-development model, and this is the most effective path to regulatory approval,” said Ken Butz, associate director of regulatory technical advisors at PPD, and the leader of a session on the evolving ...
  • ReconRecon

    Recon: HHS asserts rulemaking authority over FDA; AstraZeneca releases COVID vaccine trial blueprints

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over FDA ( NYTimes ) ( Endpoints ) ( HHS ) Democratic chairman says White House blocked FDA commissioner from testifying ( The Hill ) A Deal on Drug Prices Undone by White House Insistence on ‘Trump Cards’ ( NYTimes ) Top US Health Officials Tiptoe Around Trump’s Vaccine Timeline ( NYTimes ) Emails Deta...
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    Convergence: Thinking beyond the registry for real-world device evidence

    Medical device registries can provide rich fields for data mining when real-world evidence is sought. But most medical devices will never land on a registry. Does this mean that these manufacturers will not be able to find a source of real-world data?   Not according to Heather Colvin, who spoke during a real world evidence-focused session at RAPS Convergence 2020. Colvin is the director of evidence and outcomes policy for MD regulatory affairs at Johnson & Johnson. Sh...
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    Convergence: EMA close to finalizing guidance for advanced therapies

    The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal products containing genetically modified cells, which includes chimeric antigen receptor (CAR)-T cell therapies. The “Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells” was originally issued in 2012 but underwent revision and consultation from July 2018-July 2019. The revised version is expected to...
  • ReconRecon

    Recon: Moderna releases COVID vaccine trial blueprint; BioNTech buys Novartis’ site to boost EU vaccine production

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna would seek limited emergency use of COVID-19 vaccine based on early data ( Reuters ) ( Boston Globe ) Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial ( NYTimes ) Moderna to develop seasonal flu vaccine ( Reuters ) Biden-aligned group outlines potential Day 1 drug pricing actions ( STAT ) US plans for hundreds of millions of cheap, fast ...
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    At Convergence, CDRH details its pandemic response

    As the coronavirus pandemic swept through major US cities in the spring of 2020, the US Food and Drug Administration took unprecedented steps to address shortages and bring tests and potential therapies online with alacrity.   One center at FDA, the Center for Diagnostic and Radiological Health (CDRH), was faced with deciding how to address the potential for dire shortages of medical devices, while considering how to address such unconventional solutions as 3D printing...
  • 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...
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    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...
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    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...
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    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...
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    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...