• Regulatory NewsRegulatory News

    FDA Issues Draft Guidance on Inactive Ingredient Database

    The US Food and Drug Administration (FDA) on Wednesday released a draft guidance for public consultation providing recommendations for drugmakers on using the agency’s inactive ingredient database (IID) during drug development.   The IID is an online repository of information about excipients used in FDA-approved products and serves as a replacement for the inactive ingredient guides the agency began disseminating in the late 1980s.   Within the database, FDA pro...
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    Live Case Presentations of Investigational Devices: FDA Finalizes Guidance

    The final guidance issued on Wednesday establishes new recommendations and considerations for a live or pre-recorded broadcast of a surgical or percutaneous procedure under an investigational device exemption (IDE).   The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) provides recommendations with regard to human subject protection measures and what to include in an IDE application for sponsors seeking to conduct these broadca...
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    WHO Lays Out Five-Year Regulatory Action Plan

    As part of efforts to increase access to quality medical products around the globe, the World Health Organization (WHO) this month crafted a five-year plan to promote regulatory collaboration and reliance, and to help national regulatory authorities (NRAs) solve capacity issues and other challenges. According to WHO surveys, only 30% of NRAs in 2018 had the capacity to effectively and efficiently regulate medical products, although there was greater capacity to regulate...
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    Recon: GSK’s Dovato Hits Main Goal in Phase III Study; Trump Signs Executive Order to Boost Home Dialysis, Kidney Transplants

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The FDA's Janet Woodcock talks about some big changes she's pushing for in drug development, and agency reviews ( Endpoints ) ( Fierce ) 23andMe’s chief scientific officer, a star in drug development, is leaving role ( STAT ) ( Endpoints ) DNA-Testing Service Exposed Thousands of Customer Records Online ( Bloomberg ) CDC made a synthetic Ebola virus to test tr...
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    New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance on the US Pharmacopoeial Convention Pending Monograph Process (USP-PMP), outlining how sponsors can revise or create new monographs so they are harmonized with a new product’s FDA-approved quality and labeling requirements.   Background   New and generic drug applicants and drug master file holders must ensure that a drug product or substance complies with applicable standards in the US...
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    Comparison of Data Requirements for the Approval of a Biosimilar Versus the Reference Medicine

    This article compares and contrasts several aspects of biological products versus biosimilar products. The author defines both biologics and biosimilars and explains how and why the two differ in terms of their organic natures. She also guides the reader through the biologic vs. biosimilar developmental and testing stages and through agency approval and postmarketing surveillance. The author clarifies important points to consider when developing biologic and biosimilar pro...
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    AdvaMed Calls for Tweaks to FDA Draft Guidance on Inspections

    In two comments submitted to US Food and Drug Administration (FDA) draft guidance on inspections of medical device establishments, AdvaMed recommended several changes.   The draft guidance, issued in March, seeks to make the processes and standards for FDA inspections of device establishments uniform, per the criteria set forth under the FDA Reauthorization Act of 2017 (FDARA). Yet AdvaMed argues the draft guidance fails to deliver.   “The current wording of th...
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    EU MDR/IVDR: EC Calls for Observers to Sit on Nomenclature Subgroup

    The European Commission (EC) issued a call for applications to serve on a subgroup that will assist and advise on nomenclature-related issues, including unique device identification (UDI) and surveillance, as part of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).   The 5 July call gives industry associations and other health professionals or stakeholders until 5 August to submit applications. The EC’s Directorate-General for Internal Market, ...
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    FDA Finalizes Revised REMS Modifications Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized a revision of its guidance on making and submitting modifications and revisions to risk evaluation and mitigation strategies (REMS).   Specifically, the guidance lays out FDA’s policies for REMS modifications and revisions, including what types of changes the agency will consider and the processes and procedures for submitting those changes to the agency.   The 26-page guidance finalizes an earlier vers...
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    FDA Warns Akorn for Repeat Violations

    Following a more than one-month inspection last summer, the US Food and Drug Administration (FDA) on Tuesday released a warning letter for Akorn’s Somerset, New Jersey manufacturing facility due to cGMP violations. The warning letter, issued 13 June and discussed by Akorn on 25 June, echoes some of the observations made by FDA in a Form 483 for the site last November. FDA specifically raises concerns with the site’s quality system, which “does not adequately ensu...
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    Curiosity: One of Life’s Most Valuable Commodities

    This article discusses the value in human curiosity for learning, living a more meaningful life and as an important tool for professional success. The author reviews several books on curiosity that outline why we are curious, explains different types of curiosity and suggests how we might not lose our curiosity as we age. Introduction While working for a medical device company, I frequently had the opportunity to interview new job candidates. One question I asked was...
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    WHO Updates Lists of Essential Medicines, Diagnostics

    The World Health Organization (WHO) on Tuesday released the latest lists of essential medicines and essential in vitro diagnostic (IVD) tests, which can help countries prioritize critical health products.   The updated essential medicines list (EML) adds 51 new medicines, bringing the total to 460 medicines. The updated essential diagnostics list (EDL) adds 115 tests to the 113 tests in the first EDL version , published last May.   The focus of the EML is medici...