• Feature ArticlesFeature Articles

    Regulatory Intelligence Trends, Risk Management, Brexit and Medical Device Legislation

    Articles posted throughout February included a wide variety of topics, including regulatory intelligence, document legalization, prescription to non-prescription switches in Canada and Brexit preparation. Other articles covered medical device risk management, emerging technologies in FDA drug approval process and regulation of pharmaceutical products in Ethiopia. " Regulatory Intelligence: 2017 FDA Review and Trends to Watch ," by principal consultant Meredith Brown-Tut...
  • Feature ArticlesFeature Articles

    Ethiopian Pharmaceutical Industry Growth and Development of its Regulatory Systems

    This article examines the growth of the pharmaceutical industry in Ethiopia and presents the processes and pathways for medicinal products to gain market approval. The author emphasizes the need for a strong and well-functioning pharmacy industry given the variety of serious illnesses affecting the population of Ethiopia and its African neighbor states. Introduction Ethiopia, located in the Horn of Africa, shares borders with Eritrea to the north and northeast, Djibouti...
  • Feature ArticlesFeature Articles

    Regulatory Intelligence: 2017 FDA Review and Trends to Watch

    This article provides a variety of websites with important information on recent changes to FDA guidances and tables showing user fees, new provisions, and impact analyses. It also reviews trends and recently passed acts and provides website tools for keeping abreast of changes under the new administration. Introduction Sometimes a year will go by and the regulatory process will seem to move in geologic time (eons versus real time) and nothing new has happened. That was...
  • Feature ArticlesFeature Articles

    Medical Device Reimbursement in the US

    This article provides an overview of the history and path for reimbursement in the US for medical devices and discusses practical approaches for medical device industry professionals to integrate reimbursement strategies into product development plans and timelines to support a company's business goals and objectives. Introduction Professionals involved in product development and commercialization understand there is a cost associated with bringing goods and services to...
  • Feature ArticlesFeature Articles

    Switching Prescription Drugs to non-Prescription Status in Canada

    This article provides an overview of the prescription to non-prescription switch process in Canada. The author examines factors to be considered in determining drug scheduling and provides an overview of the prescription to non-prescription process at both the federal and provincial/territorial levels, highlighting the often-complex details of the switch with illustrative examples of recent switches . Introduction In Canada, there are federal and provincial/territorial...
  • Feature ArticlesFeature Articles

    US Apostille and Consular Legalization: Critically Important, Often Overlooked

    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

    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

    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

    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

    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...
  • Feature ArticlesFeature Articles

    A Regulatory Perspective: FDA Final Guidance for Design Changes Requiring new 510(k) Submissions

    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...
  • Feature ArticlesFeature Articles

    Journey of a Drug From Concept to Approval

    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...