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  • Regulatory NewsRegulatory News

    FDA Flags Incidents of Excess Radiation Exposure to Patients

    The US Food and Drug Administration (FDA) imposed a boxed warning on the labeling of rubidium 82 generators, which are used with Positron Emission Tomography (PET) heart perfusion imaging scans. The agency circulated the drug safety alert on Monday in response to recent excess radiation exposure incidents. Manufacturers Bracco Diagnostics and Jubilant DraxImage also sent letters last month to inform health care providers about incidents of patients’ exposure to high lev...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Minimizing X-Ray Radiation for Children

    The US Food and Drug Administration (FDA) on Monday finalized guidance aimed at reducing the amount of radiation children are exposed to from x-ray imaging devices. While x-ray imaging can increase the risk of cancer for both adult and pediatric patients, FDA says that radiation is a greater concern for pediatric patients as they are more sensitive to radiation and have a longer expected lifetime during which cancer could develop. FDA also says that x-ray imaging devices...
  • Regulatory NewsRegulatory News

    FDA Officials Question Lack of New Cancer Drugs Developed in Combination With Radiation

    Although almost half of patients with cancer who are cured will have received radiation therapy as a component of their care, there is still a dearth of new therapies being developed in combination with radiation, officials from the US Food and Drug Administration (FDA) wrote in an article published this week. The authors, including Richard Pazdur, director of FDA's Oncology Center of Excellence, and FDA medical officer Amanda Walker, say that since 2006 there have been ...
  • Regulatory NewsRegulatory News

    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...
  • FDA Hopes to Leverage Regulatory Science to Protect Public from Nuclear, Radiologic Threats

    The US Food and Drug Administration's (FDA) may be most known for its drug and device approvals intended to treat relatively common ailments-diseases, infections, cancer and inherited conditions-but every so often its activities venture into more exotic areas of regulation. Regulation: The Exciting Stuff Such an area was on display in a 12 August 2013 announcement in which FDA said it had awarded a $5.6 million contract to Harvard University to assess new medical counte...
  • US Regulators Want New Look at Radiation-Emitting Products

    Medical device regulators with the US Food and Drug Administration (FDA) stand to benefit from a new support program announced on 28 January 2013 that promises to support the agency's mission of better protecting consumers against radiation. That support, announced in a Federal Register posting , will come in the form of a grant awarded to an entity that FDA expects will be able to facilitate cooperation between state, federal and tribal entities in order to improve ra...
  • Reports: Unsecured Nuclear Material Used in Medical Devices a Threat to National Security

    Regulators with the US Food and Drug Administration (FDA) regularly deal with matters of public health. From monitoring disease outbreaks to assessing products for safety and conducting postmarketing vigilance, the agency is often positioned at the bleeding edge of technology, risk and safety. But far from limiting itself to only the threats that currently exist, it has in the past decade begun to increasingly look to threats that don't exist and how it might position it...
  • Could Radiation Exposure Recommendations Affect an Impending App Guidance?

    The US Food and Drug Administration (FDA) may be in the midst of increasing cellphone use by developing its mobile medical application guidelines, but at least one government agency and a US legislator are calling for additional research on the effects of radiation emitted from the phones themselves. In a 24 July report released by the Government Accountability Office (GAO), the government's internal program watchdog, the agency said a reassessment of the effects of ra...
  • 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...