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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 25 February 2020 to include: Vifor Pharma said on 17 February that it p...
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    Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting

    On 6 and 7 November, a US Food and Drug Administration (FDA) medical devices advisory committee will meet to discuss the use of ethylene oxide (EO) to sterilize medical devices and the risks of infection with reprocessed duodenoscopes. The meeting comes as the agency is actively exploring new methods of sterilization, as sterilization facilities have closed down in recent months because of environmental concerns with emissions and as postmarket surveillance studies ...
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    MDR/IVDR Guidance: MDCG Explains What’s Coming

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday unveiled its plans for releasing almost 50 future guidance documents related to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the bulk of the new guidance coming on the oversight of notified bodies (NBs) and clinical investigations and evaluation (CIE). The list also notes that much of the guidance will be endorsed by the MDCG later this year or in 202...
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    FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements

    Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) on Thursday proposed to exempt additional class II medical devices under five different product codes from 510(k) requirements. The proposed exemptions follow the finalization of a list in July 2017 of 1,003 types of class II devices that the agency also said do not present risks that require premarket notification. But for four of the five product codes proposed on Thursday, FDA has ...
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    FDA Modifies List of Standards for Premarket Device Reviews

    The modified list of standards published on Wednesday is meant to assist medical device manufacturers that elect to declare conformity with consensus standards to meet certain US Food and Drug Administration (FDA) requirements. Back in 1997, the Food and Drug Administration Modernization Act allowed FDA to recognize consensus standards developed by national and international organizations to satisfy certain portions of device premarket review submissions or other requ...
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    Submitting Manufacturing Facility Information: Final FDA Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized a question and answer guidance on the type of manufacturing facility information that should be included in applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. FDA explains that the guidance is meant to help companies understand how not to submit extraneous information or misplaced or missing information that could result in delays, Refu...
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    Where are the Interchangeable Biosimilars?

    In June 2017, Leah Christl, former biosimilar lead at FDA, told a conference in Chicago that interchangeable biosimilars were likely coming to the US market within two years . And although no interchangeable biosimilar has been approved by FDA yet, and Christl has since moved on to Amgen , progress on interchangeable biosimilars has been made, albeit slowly, in the intervening years. Most recently, Boehringer Ingelheim announced that it has completed , as of last ...
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    FDA Addresses Questions on 510(k) Third-Party Review Program

    The US Food and Drug Administration (FDA) recently responded to several comments related to a 2018 draft guidance on its 510(k) third-party review program, which was crafted because of the latest reauthorization of the Medical Device User Fee Act . The third-party review program is intended to allow for the review of devices by certain outside organizations to provide manufacturers of lower risk devices with an alternative review process that allows FDA to best utilize...
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    2020 Guidance: CDRH Offers a Look at What’s Coming

    FDA’s Center for Devices and Radiological Health (CDRH) on Friday released its FY 2020 draft and final guidance list, which features a few repeats from last year and new drafts coming on device servicing and remanufacturing, unique device identification and patient-reported outcome measures used in device submissions, among others. As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft an...
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    FDA Clears First Rapid Diagnostic Test for Ebola

    The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on Thursday allowed the marketing of the first rapid diagnostic test for the Ebola virus that has not been authorized via the agency’s Emergency Use Authorization (EUA) pathway. OraSure Technologies’ OraQuick Ebola Rapid Antigen Test, which provides a rapid, presumptive diagnosis that must be confirmed, gained market entry via CDRH's De Novo review pathway less than five mont...
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    FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials

    As part of a push to reduce administrative burdens, the US Food and Drug Administration (FDA) on Wednesday finalized guidance on an optional streamlined submission process for determining the risk of an investigational in vitro diagnostic (IVD) in a clinical trial where an investigational IVD is being co-developed with an oncology investigational drug. The submission process, first proposed in draft guidance in April 2018 , is meant to help sponsors determine if an IVD...
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    FDA Unveils New Tables for Submitting Bioanalytical Methods

    The US Food and Drug Administration (FDA) recently released tables that can be included in submissions for new drug and biologic applications to provide information regarding the bioanalytical methods for pharmacokinetic assessments. “The templates in this guidance are applicable to bioanalytical procedures such as chromatographic assays (CCs) and ligand-binding assays (LBAs) that quantitatively determine the levels of drugs and their metabolites and therapeutic protein...