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  • Regulatory NewsRegulatory News

    Generic drugmakers get cannabidiol bioequivalence guidance from FDA

    Manufacturers who seek to produce generic versions of cannabidiol oral solution received guidance from the US Food and Drug Administration (FDA) on establishing bioequivalence with the reference listed drug.   The guidance follows the June 2018 approval of Epidiolex (cannabidiol) oral solution to treat seizures associated with two rare and serious types of childhood epilepsy. Epidiolex was also approved to treat a third seizure condition, tuberous sclerosis complex, in...
  • Regulatory NewsRegulatory News

    COVID-19 vaccine: Experts warn of waning public confidence

    Conflicting messages and priorities between vaccine makers and federal leaders serve only to exacerbate public mistrust of potential COVID-19 vaccines, according to a perspective piece from Harvard professors published in the New England Journal of Medicine .   Jerry Avorn, MD, and Aaron Kesselheim, MD, both from the division of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School, took to the august publication to share their thoughts on the juxtaposi...
  • Regulatory NewsRegulatory News

    Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance

    Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel coronavirus pandemic, according to an updated guidance from the US Food and Drug Administration (FDA).    The updated information came on 21 September 2020 in the form of a new addition to the questions and answers in the FDA's guidance on conduct of clinical trials of medical pro...
  • Regulatory NewsRegulatory News

    FDA releases guidance on inclusion of geriatric information in drug labeling

    The US Food and Drug Administration (FDA) has issued draft guidance on the content and placement of information specific to geriatric patients in drug and biologic labeling.   The guidance document, issued in September 2020, replaces a previously withdrawn guidance document – “Content and Format for Geriatric Labeling” – initially released in October 2001.   The new draft guidance provides examples of specific geriatric use statements and examples of when the FDA...
  • ReconRecon

    Recon: COVID vaccine makers see EU liability shield; BMS lands FDA priority review for ide-cel CAR-T therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Decision Time Looms for Biotech’s Riskiest Bet ( WSJ ) After bruising rejection, bluebird and Bristol Myers Squibb land ide-cel priority review. But will it matter for the CVR? ( Endpoints ) ( Press ) Medicare Wouldn’t Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization ( WSJ ) CDC Advisory Panel to Delay Vote on Initial...
  • 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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...