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  • Feature ArticlesFeature Articles

    Latin America market opportunities for food supplements: Navigating regulatory complexities

    This article discusses the growth opportunities in Latin America for food supplement businesses. It provides guidance for companies eager to interpret current regulation, predict future direction, and plan successful commercial strategies. The author addresses the commercial advantages going along with increased regional and global harmonization and how to navigate current regulatory complexities to realize commercial opportunities and meeting the challenges and opportunit...
  • Regulatory NewsRegulatory News

    Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward

    This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory frameworks for food and dru...
  • Regulatory NewsRegulatory News

    FSMA and its Impact on Dietary Supplement Companies

    This article discusses FSMA-related regulations and stresses the impact the regulations will have on the dietary supplement industry. Introduction Since the Food Safety Modernization Act (FSMA) was signed into law in January of 2011, regulatory professionals in the food and dietary supplement areas have been barraged. 1 Seldom has one act had as many touch points in food regulation. For dietary supplement companies, FSMA's broad scope and hefty volume have made it a ...
  • Regulatory NewsRegulatory News

    The US Regulatory Environment for Probiotics in Food

    This article discusses the US Food and Drug Administration's (FDA's) revised draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, and its potential impact on the regulatory status of probiotic ingredients. It outlines the opportunities for probiotics as medical foods, as well as the potential regulatory challenges associated with this category. The author encourages probiotics manufacturing companies to engage in 'self-regulatory ...
  • Regulatory NewsRegulatory News

    Intractable Epilepsy and the Value of Formulated Ketogenic Diet Products

    This article discusses the benefits of the Ketogenic Diet (KD) and the Modified Atkins Diet (MAD) for adults and children as treatments for intractable epilepsy. It offers a patient-oriented interpretation of regulatory requirements for medical foods as well as study data demonstrating KD efficacy. The article was based on a presentation given at the 2017 RAPS Convergence, during the medical food session on Modification of Diet Alone (MODA) vs. access and convenience mat...
  • Regulatory NewsRegulatory News

    Overcoming Distinctive Regulatory Barriers for the Development of Medical Foods

    This article compares the legal definitions of drugs and medical food and outlines the distinctive regulatory hurdles for medical food, in particular, the need for substantiating distinctive nutritional requirements. The authors also make recommendations on how those regulatory hurdles could be overcome with definitive regulatory guidance for both distinctive nutritional requirements (DNR) and modification of normal diet alone (MODA). Introduction Novel nutrition ther...
  • Regulatory NewsRegulatory News

    FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND

    The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency. FDA officials advised the company last July, before initiating the clinical trial that “although these were Medical Foods and no NDA would be applied for, Targeted Medical Pharma should still apply for an IND.”...
  • Regulatory NewsRegulatory News

    EMA Looks to Revise Guideline on Investigation Drug Interactions

    The European Medicines Agency (EMA) has proposed to change the agency's guideline for investigating drug interactions. The guideline, last updated in 2012, details how drugmakers should conduct interaction studies to evaluate the potential for drug-drug and drug-food interactions. "Drug-drug interactions are a common problem during drug treatment and give rise to a large number of hospital admissions as a result of medically important, sometimes serious or even fatal ad...
  • Regulatory NewsRegulatory News

    Canada to Require Drugmakers to Publicly Disclose Drug Shortages

    Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca. “As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a...
  • Feature ArticlesFeature Articles

    CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions

    To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and ...
  • Regulatory NewsRegulatory News

    Nutrition, Health and Disease Management, Hot Topics and a Preview of September

    New Food Regulatory Paradigms: The Right Paths for Nutrition, Health and Disease Management The August collection of feature articles for Regulatory Focus explores the changing healthcare paradigms when food (health) and drug (disease) systems, once separate silos, are now moving closer together. This creates new opportunities, yet also gray zones, making historic pharmaceutical and nutrition "models" prone to be revisited. Leading global experts in their respective fi...
  • Feature ArticlesFeature Articles

    Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities

    This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world. The regulatory criteria that a medical food/FSMP be uniquely formulated to address distinctive nutritional requirements for patients wit...