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  • Regulatory NewsRegulatory News

    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...
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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...
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    How to assess symptoms in COVID-19 trials: new FDA guidance

    Investigators should use a patient-reported outcomes approach, with an emphasis on electronic data collection, in their research on therapies to treat or prevent COVID-19, according to a new guidance from the US Food and Drug Administration (FDA). The guidance, which is effective immediately during the public health emergency of the coronavirus pandemic, outlines how to capture disease-related symptoms in clinical trials focusing on COVID-19 prevention or treatment for ...
  • 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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    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...
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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...
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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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    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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    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...