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  • Feature ArticlesFeature Articles

    IVDR, notified bodies, and technical documentation: The devil is in the detail

    This article discusses notified body expectations for the technical file and provides some practical tips for preparing submissions.   Introduction The “devil is in the detail” is a phrase I’m using a lot these days, and it is a feature of the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746 1 that is tripping up IVD manufacturers as they make their first submissions.   The IVDR states in Annex II that:   The technical documentation and, if applicable...
  • Feature ArticlesFeature Articles

    Implementing the MDR: Slowing down on the homestretch?

    With the most recent delay to 26 May 2021 as the date of application for the European Medical Device Regulation (MDR) 1 still fresh in our minds, 2 many wonder if it is a matter of time before we hear about the next extension. It’s a valid question, as many manufacturers still have a long way to go until they are fully compliant with the new rules and expectations. However, it does not do justice to the differences between the circumstances at the start of the first wave...
  • Regulatory NewsRegulatory News

    HHS seeks drug importation waiver applicants

    The US Department of Health and Human Services (HHS) has issued a request for proposals (RFP) from individuals who wish to seek waivers permitting them to import prescription drugs from certain countries.   The RFP, issued 24 September 2020, provides a pathway for individuals who have waivers to import some FDA-approved drugs through authorized state-licensed pharmacies. Countries considered an “acceptable foreign source” by HHS for the purposes of the waiver include A...
  • Regulatory NewsRegulatory News

    Former commissioners call on administration to end FDA criticism

    Seven former commissioners of the US Food and Drug Administration (FDA) came together to call out the Trump administration for undercutting FDA’s credibility as the agency prepares to evaluate clinical trial data for vaccines against SARS-CoV-2, the virus causing the novel coronavirus pandemic.   Their comments, made in an opinion column published 29 September in The Washington Post , were welcomed by the FDA’s current vaccines chief, Peter Marks , MD, PhD, directo...
  • Regulatory NewsRegulatory News

    FDA warns of infection risk with CardioQuip heater-cooler

    The US Food and Drug Administration (FDA) on Wednesday warned health care providers about the potential risk of Mycobacterium abscessus , a type of nontuberculosis mycobacteria (NTM), infection during cardiac surgery when using CardioQuip’s Modular Cooler-Heater.   The warning is the latest in a series of safety communications and other regulatory actions related to heater-cooler devices since 2015 , when FDA first raised awareness of the risk of NTM infection post...
  • RoundupsRoundups

    FDA Approvals Roundup: Nucala, Fetroja, Xeljanz

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Nucala gets expanded indication for HES GlaxoSmithKline’s Nucala (mepolizumab injection) has been granted a new indication for the treatment of hypereosinophilic syndrome (HES) in adults and children 12 years and older. The indication is for patients who have had HES for six months or longer, with no other identifiable nonblood-related cause o...
  • ReconRecon

    Recon: House kicks off two-day hearing on drug prices; Moderna COVID-19 vaccine appears safe in early study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna COVID-19 vaccine appears safe, shows signs of working in older adults ( Reuters ) ( NEJM ) All Eyes Are on Pfizer as Trump Pushes for Vaccine by October ( NYTimes ) Trump’s debate highlights his hunger for a rushed, election-eve vaccine approval ( STAT ) Trump claims his policies made insulin ‘so cheap, it’s like water.’ But for most people, it costs j...
  • Feature ArticlesFeature Articles

    Regulation of cell and gene therapy products in China

    This article provides an overview of the Chinese regulations and guidance documents for cell and gene therapy products (CGTPs).   Introduction As early as 1993, Chinese regulators provided guidance on clinical research for somatic cell and gene therapy. More regulations, laws, and guidances have since been published, either specific to, or including, CGTPs. The two most recent publications have been draft guidelines for clinical studies for immune cell therapy produc...
  • Regulatory NewsRegulatory News

    Hahn insists FDA will stick to guidelines for COVID-19 vaccine decisions

    Speaking at the Financial Times ’ US Pharma and Biotech Summit on Tuesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said the agency will stick to the standards and criteria it has laid out to approve or authorize applications for vaccines to prevent coronavirus disease (COVID-19).   In recent weeks, Hahn has made numerous statements asserting that the agency will not approve or authorize a vaccine that does not meet the agency’s “rigorous expect...
  • Regulatory NewsRegulatory News

    HHS, to address insulin price crisis, issues RFP for reimportation

    The US Department of Health and Human Services (HHS) has issued a request for proposals for reimportation of insulin produced in the United States and exported for sale abroad.   The measure, said HHS, is meant to address the fact that “The rising price of insulin, and corresponding rationing of insulin, constitutes an emergency” within the US. The agency noted that insulin prices rose nearly six-fold between 2002 and 2016. One commonly prescribed insulin, said HHS, ha...
  • Regulatory NewsRegulatory News

    Study calls for proactive surveillance of device AEs

    The US Food and Drug Administration (FDA) relies mainly on direct reports and regulator-initiated surveillance to flag safety concerns around medical devices, a system that may delay detection of adverse events (AEs), according to a new analysis published in JAMA Internal Medicine . “These data highlight the importance of proactive identification of postmarketing device-related safety issues to provide health care professionals with more complete data regarding potenti...
  • Regulatory NewsRegulatory News

    Drug mutagenicity, proarrhythmic potential addressed in pair of FDA guidances

    The US Food and Drug Administration (FDA) has issued two new draft International Council on Harmonisation (ICH) guidelines for public consultation.   A question-and-answer (Q&A) guidance on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of medicines was published in draft form by FDA on 29 September; the guidance is currently in ICH Step 2b, awaiting consultation from the Council's participating countries. The draft guid...