• Feature ArticlesFeature Articles

    US Apostille and Consular Legalization: Critically Important, Often Overlooked

    • 16 February 2018
    • By David L. Watt
    Every regulatory department must manage document requirements either internally or by engaging an outside service. This article covers the process for "legalizing" documents to sell regulated products outside of the US. A US product cannot be sold overseas without proof of the legalized document. Introduction Apostille. Consular Legalization. Certificate to Foreign Government. Certificate of Pharmaceutical Product. Certificate of Free Sale. ISO Certificates.  These ter...
  • Feature ArticlesFeature Articles

    Medical Device Risk Management

    • 14 February 2018
    • By Darin OppenheimerSuraj Ramachandran
    This article focuses on risk management in the medical device industry and reviews organizational competencies, processes and resources as well as beliefs and behaviors. The authors conclude that, especially in the later phases of product development, not enough attention is paid to risk management tools. Introduction In our previous article, "Organizational Culture and Memory in Managing Risk in the Medical Device Industry" ( Regulatory Focus, August 2017), we discuss...
  • Feature ArticlesFeature Articles

    FDA's Workshop on Troponin Assays Approval Fosters Agreement, Debate

    • 08 February 2018
    • By Judi SmithKaren Richards
    This article discusses a recent FDA workshop held for troponin assays, tests designed most commonly to detect the release of cardiac troponin following Acute Myocardial Infarction (AMI). The authors review the history, uses and issues associated with using troponin - a three protein complex, released rapidly into the blood after myocardial injury - and innovative medical devices to detect troponin levels, as an assay to aid in the diagnosis of an AMI event. Regulatory pro...
  • Feature ArticlesFeature Articles

    How EU Marketing Authorization Holders Prepare for Brexit

    • 08 February 2018
    • By Kathrin Schalper
    This article focuses on the regulatory consequences for EU Marketing Authorization Holders (MAHs) of medicinal products under Brexit. The author discusses various ways to prepare for post-Brexit outcomes using "scenario analysis," a preliminary and step-wise analysis for evaluating a variety of possibilities and implications following the UK's withdrawal from the EU. Introduction In a referendum conducted in the United Kingdom (UK) in June 2016, 51.9 percent of voters w...
  • Feature ArticlesFeature Articles

    January Features Examine the Latest on Regulatory Intelligence, Policy and Trends

    • 05 February 2018
    • By Gloria Hall
    How can regulatory trends be identified? What are best practices for commenting on new or revised regulatory documents? And, what's going on with the EU revisions to medical device regulatory requirements? January's feature articles are alive with answers to these thorny questions and some of the most experienced regulatory professionals have provided their best advice. Pharmacist and attorney, Benjamin Chacko , who served as regulatory counsel for US FDA, looks back at...
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    A Regulatory Perspective: FDA Final Guidance for Design Changes Requiring new 510(k) Submissions

    • 05 February 2018
    • By Jeff Ryberg
    This article explores key elements of FDA's final guidance to the medical device industry for deciding when to submit a new 510(k) for medical device hardware and software design changes issued 25 October 2017. The author assesses the potential business impact and suggests what companies need to do to align with FDA's final guidance. Introduction In response to technological advancements, broadening medical knowledge and clinical use, medical device designs frequently...
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    Journey of a Drug From Concept to Approval

    • 31 January 2018
    • By Sharry AroraBhaskar Saxena
    This article reviews the process of getting a new drug to market from the laboratory to the pharmacy. It addresses discovery and the developmental stages along the way, including finding lead compounds (drug discovery), target validation (drug development), and testing through pre-clinical trials, clinical trials, and post-production studies for acquiring marketing and long-term safety data. Introduction A molecule's journey from laboratory concept to a consistent and w...
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    The Drug Regulatory Landscape in the ASEAN Region

    • 29 January 2018
    • By Abhishek Tongia
    By Abhishek Tongia This article provides an overview of critical regulatory requirements to be considered for Association of Southeast Asian Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical products, regulatory submissions, pharmacopoeia, halal compliance, stability requirements, pharmacovigilance, product labeling, and drug variation information. Introduction The Association of Southeast Asian Nations (ASEAN) has diverse regulatory re...
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    How to Determine Whether to Comment on Regulatory Documents

    • 26 January 2018
    • By Kimberly BelskyEmily HuddleElizabeth Rosenkrands-Lange
    By Kimberly Belsky, Emily Huddle and Elizabeth Rosenkrands-Lange This article addresses the question whether to submit comments to health authorities regarding new regulatory documents or proposed changes to existing documents. The authors provide several considerations for making such decisions as well as ways of determining if the submitted comments have been "successful." Introduction When deciding whether it is useful or beneficial for a company to offer comments o...
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    Developing Regulatory Policy: Recollections of H1N1

    • 26 January 2018
    • By Benjamin A. Chacko
    This article provides an overview of how regulatory policy is developed at US Food and Drug Administration (FDA) and specifically in FDA's Center for Biologics Evaluation and Research (CBER), using the 2009 H1N1 swine flu event as a "backdrop." The discussion focuses on enacting clear and transparent policies and also protecting both the public welfare and industry's goals. Introduction In May 2009, as a new employee of US Food and Drug Administration's Center for Biolo...
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    Biomarker Data Management in Clinical Trials: a Model for Success Under New FDA Data Exchange Standards

    • 26 January 2018
    • By Jared KohlerTobias Guennel
    This article discusses challenges for researchers pursuing biomarker research and collecting speciality laboratory data increasingly used for FDA drug submissions and requiring datasets that meet new regulatory standards. The authors review new technologies for biomarker data management, leveraging technology and subject matter expertise aimed at gaining improved flexibility, efficiency and compliance. Introduction New US Food and Drug Administration (FDA) data exchange...
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    Monitoring, Analyzing and Interpreting Regulatory Trends

    • 24 January 2018
    • By João Duarte
    This article discusses ways in which the regulatory intelligence professional can monitor, identify, analyze, interpret and "stay on top" of regulatory trends to best develop regulatory strategies aimed at maintaining the organization's regulatory compliance readiness. Sources to help identify regulatory trends as well as ways to develop skills for trend analysis and interpretation are examined. Introduction One fundamental responsibility of regulatory intelligence and ...