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    Final FDA Guidance Focuses on Diagnostics Measuring Radiation Exposure

    The US Food and Drug Administration (FDA) has finalized guidance detailing the types of data and study considerations necessary to support the approval of diagnostics intended to measure levels of unintended radiation exposure in patients. Unlike physical dosimetry devices, which measure the actual dose of radiation delivered to a patient, the guidance deals with biodosimetry devices , which measure a patient's physiological, biological or chemical response to radiation...
  • EC Committees: Changes Coming to European Human Risk Assessment

    • 22 October 2012
    A new discussion paper generated by three of the EU's top scientific committee has called for a paradigm shift in the way regulators assess risks to human health from a hazard-driven process to one driven by exposure. The paper, Addressing the New Challenges for Risk Assessment , was issued by three of the European Commission's Scientific Committees: the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), the Scientific Committee on Consumer ...
  • Regulation, Security of Nuclear Materials Used in Health Products Questioned

    US Nuclear Regulatory Commission (NRC) rules governing how radioactive materials are stored and secured are coming under additional scrutiny after a US Government Accountability Office (GAO) report showed physicians were largely untrained and unprepared to accommodate the materials. Radioactive materials are regularly used in medical devices and cancer treatment, and the security of those materials has generally fallen under the responsibility of hospitals. Post-9/11 con...