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  • Feature ArticlesFeature Articles

    Genetically Engineered Foods and their Regulation: the Way Forward after Twenty Years of Adoption

    This article reviews the US history and impact of Genetically Engineered (GE) crops over two decades, explains the federal oversight of GE crops and suggests improvements to federal oversight to ensure the safety of GE crops and greater consumer confidence in GE foods. The article also discusses public attitudes toward GE foods and the issues surrounding the labeling of those foods, including the law requiring mandatory disclosure signed by President Obama on 29 July 201...
  • Regulatory NewsRegulatory News

    Company Calls on FDA to Speed Authorization of Genetically Modified Mosquitoes to Fight Zika Virus

    As the US Food and Drug Administration (FDA) continues to debate whether to allow Britain’s Oxitec to release genetically modified mosquitoes into Florida and other vulnerable areas as a means of controlling the spread of the Zika virus, the company’s CEO told a House committee Wednesday that time is running out. Oxitec CEO Hadyn Parry, who testified before the House Committee on Science, Space and Technology, told the representatives that the company’s GM mosquito is sa...
  • Regulatory NewsRegulatory News

    EMA Unveils 19 Advanced Therapy Product Classifications

    The European Medicines Agency (EMA) on Tuesday released a host of classification decisions for advanced therapies being developed to treat various types of tissue damage, including burns, scars and non-healing wounds. The agency, through its Committee for Advanced Therapies (CAT), offers sponsors an optional consultation to determine whether a product meets the criteria for an advanced-therapy medicinal product (ATMP) . The classification procedure is laid out in Arti...
  • Regulatory NewsRegulatory News

    FDA Bans Import of Genetically Engineered Salmon

    The US Food and Drug Administration (FDA) has issued an alert banning the import of genetically engineered (GE) salmon, months after approving the first such animal as safe to eat. The import alert helps the agency comply with the FY 2016 omnibus spending bill President Obama signed into law in December. The law ordered FDA to block imports of GE salmon until the agency issues final guidance requiring food derived from GE salmon to be labeled as such. The law also requi...
  • Genetically Modified Food, Nanomaterials among Topics Addressed in Planned 2013 CVM Guidances

    The US Food and Drug Administration (FDA) has announced guidance documents its Center for Veterinary Medicines (CVM) plans to publish by the end of the 2013 calendar year, including several topics that could be harbingers for the rest of the pharmaceutical industry. The publication of the guidance list follows similar publications of documents for medical device and pharmaceutical products , and includes a number of important guidance documents. Of note: Draft Guida...
  • Researchers Call for New Regulatory Framework for Transgenic Plant-Derived Products

    • 21 February 2013
    Drug manufacturing-the regulator-approved pharmaceutical type, anyways-has traditionally been conducted at inspected facilities large and small. Everything from small compounding facilities and mid-sized laboratories to massive manufacturing plants have churned out medical products for the world. But how do you regulate a manufacturing plant that's quite literally a plant? Call it pharming, if you will. Around the world, manufacturers are already experimenting-and in so...
  • EMA Adopts Guidance on Medical Products Containing Genetically Modified Cells

    The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified cells. The scientific guideline addresses the three main areas of drug development: quality considerations within the manufacturing process, non-clinical testing and clinical testing. EMA notes genetically modified cells may either be used as therapies themselves or as part of t...
  • European Commission Demands Bulgaria 'Correctly Implement' Regulatory Legislation

    • 27 April 2012
    What happens when an EU country fails to "correctly implement" a legislative directive? A harsh scolding from the European Commission (EC) and threats to haul the country before a the European Court of Justice. That's the lesson Bulgaria is learning today, as the EC fired off a statement to the country demanding it put Directive 2009/41/EC-which regulates "activities around genetically modified micro-organisms such as when they are cultured, stored, transported, destroye...