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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

    Industry to FDA: Why Publicize Unsubstantiated Device Safety Signals?

    Industry groups are raising some serious questions with the US Food and Drug Administration’s (FDA) proposal to release emerging safety signals to the public even before those signals have been substantiated. In January, FDA released draft guidance outlining how it plans to track and release early signals on medical device safety. The release of such information is expected to be for concerns that have yet to be fully analyzed, validated or confirmed by the agency and ...
  • 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...
  • NICE Restricts GE's Diagnostic Test to Research Use

    General Electric (GE) Healthcare's diagnostic test (SeHCAT) for bile acid malabsorption in patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and Crohn's disease without ileal resection has been restricted for research use by the National Health Service (NHS) according to  draft guidance  issued yesterday by the National Institute for Health and Clinical Excellence (NICE).  The draft recommends restricting SeHCAT to research settings in or...
  • Report: India Moving to Regulate Biotechnology Research

    The Indian government is preparing to establish a new regulatory agency in charge of regulating biotechnology product research, transport, import, manufacture and use, reports The Economic Times . The new authority, tentatively known as the Biotechnology Regulatory Authority of India (BRAI), would be established under a new draft bill before the Indian parliament. The agency, in addition to its other duties, would also be in charge of formulating a risk assessment a...