• Regulatory NewsRegulatory News

    CDRH Issues Final Orders on 6 Medical Device Classifications

    A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.   The final orders cover devices indicated for use in surgery, ophthalmology, anesthesiology and neurology, and classify five new device types into class II (special controls) and one into class I. The classifications were developed based on the de novo classification requests CDRH rece...
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    CDRH Works to Develop Proposed De Novo Regulation

    The regulatory review pathway for novel devices will receive major policy clarifications by mid-2019, program lead at the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) said during a forum at RAPS’ 2018 Regulatory Convergence. The de novo program—established about 20 years ago as a mechanism to evaluate devices that are by statute automatically classified into Class III—saw an anomaly in 2017 prior to its first user fees, noted...
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    De Novo Classifications: FDA Drafts Guidance on Acceptance Reviews, Finalizes Guidance From 2014

    Following the creation of a new De Novo classification request user fee under the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV) of $93,017 (small businesses pay $23,254), the US Food and Drug Administration (FDA) on Friday released one final guidance and one draft guidance. The draft and final guidance come as FDA has seen an increased De Novo submission volume, from 42 submissions in 2014 to 69 in 2017. The draft guidance, when finalized...
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    FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

    The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV). In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a n...
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    Spain Reimbursement Profile

    This profile summarizes the reimbursement process in Spain, presents key stakeholders and highlights what should be considered early in the development process. Obtaining regulatory approval for medicines is the first major hurdle of most pharmaceutical and biotechnology companies looking to launch their products worldwide. However, obtaining market access once products are authorized by regulatory agencies (e.g., AEMPS) is a separate and crucial process without which ...
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    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...
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    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...
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    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...
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    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...
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    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 (...
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    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 ...
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    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 ...