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  • Regulatory NewsRegulatory News

    Novo Nordisk Pays $58M to Settle REMS Allegations

    Danish drugmaker Novo Nordisk on Tuesday agreed to pay $58 million to settle allegations that the company failed to follow the risk evaluation and mitigation strategy (REMS) for its blockbuster diabetes drug Victoza (liraglutide). Victoza, Novo's top-selling drug, brought in more than $1.8 billion in sales in the first half of 2017 , accounting for 20% of the company's overall sales. The allegations stem from a federal investigation into Novo's marketing practices that...
  • Regulatory NewsRegulatory News

    Proposed and Final FDA Rules: What’s Left in 2017

    The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings. Proposed Rulemakings Among the proposals coming are rulemakings dedicated to pediatric study plan requirements , internal decision making and supervisory review at FDA’s Center for Devices and Radiological Health, the withdrawal of a regulation that a...
  • Regulatory NewsRegulatory News

    Novo Nordisk Warns of Possible Cracks in Insulin Devices

    Novo Nordisk A/S on Wednesday warned people with diabetes that it has detected that the insulin cartridge holder used in a select number of NovoPen Echo and NovoPen 5 lots may crack or break if exposed to certain chemicals, including certain cleaning agents. Novo spokesman Ken Inchausti told Focus that this is a global recall. Certain lots of the two devices distributed in Canada were the subject of an initial warning . Other lots distributed in the US were par...
  • Regulatory NewsRegulatory News

    FDA Classifies Post-Concussion Test

    Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices. In August, FDA cleared ImPACT Applications' Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices via its de novo classification pathway, as no similar devices had been previously cl...
  • Regulatory NewsRegulatory News

    EMA Recommends Nine Drugs for Approval

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics. As for the new medicines, CHMP recommended granting a marketing authorization to CSL Behring’s Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with hemophilia A, Novo Nodisk’s Fiasp (...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Clinical Trial Delays Prompt EMA to Consider Revising Guidance (18 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Complaints About Delayed Clinical Trial Starts Prompt EMA to Consider Revising Guidance The European Medicines Agency (EMA) is considering revising its guidance on clinical trial reference safety information (RSI) after drug developers complained the current situation is delaying the start of studies. In response to the grievances, EMA has encouraged the industry to discuss ...
  • Regulatory NewsRegulatory News

    Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals?

    Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated. In January, FDA released draft guidance outlining how it plans to track and release early signals on medical device safety. The release of such information is expected to be for concerns that have yet to be fully analyzed, validated or confirmed by the agency and ...
  • Regulatory NewsRegulatory News

    OpenFDA Releases Huge Trove of Medical Device Data

    On Monday, the US Food and Drug Administration (FDA) released a vast amount of medical device data to its openFDA platform. Background The openFDA initiative was originally born from an order from the White House , which called for federal agencies to implement a new " digital strategy " to make government information more accessible to the public. The strategy focused on creating APIs – not active pharmaceutical ingredients, but application program interfaces – that ...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • Regulatory NewsRegulatory News

    FDA Approving New High-Risk Devices at Fastest Pace in Last Decade, Report Finds

    A new analysis by the California Healthcare Institute (CHI) indicates that after years of unprecedentedly high review times, the US Food and Drug Administration is finally beginning to accelerate the pace at which it reviews innovative high-risk medical devices. Background The data, contained in CHI's report, Taking the Pulse of Medical Device Regulation and Innovation , found broad improvement at FDA's Center for Devices and Radiological Health (CDRH), which...
  • Regulatory NewsRegulatory News

    Flip a Coin: FDA Approves Kidney Diagnostic With 50% False Positive Results

    Risk and benefit are nothing if not relative concepts. A product can have a laundry list of dangerous side effects, but so long as it treats an even more dangerous indication, it can still be approved by regulators. Conversely, a product may present no side effects whatsoever, but if it lacks efficacy, it might still be rejected by regulators. The very heart of the regulatory process is determining which products ought to be approved, and which ones don't quite pass must...
  • Regulatory NewsRegulatory News

    Public Citizen Again Calls for Ban on Diabetes Drug Victoza

    A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths. Background Victoza was approved by FDA in 2010 as a once-daily injectable treatment for Type 2 diabetes. The drug is an incretin mimetic drug known as a glucon-like peptide-1 (GLP-1) receptor agonist. At the time of its approval, FDA noted...