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    FDA Guidance Aims to Clarify Development of Medical Countermeasures

    A new final guidance document issued by the US Food and Drug Administration (FDA) aims to make it easier to develop in vitro diagnostic devices (IVDs) intended to act as microbiological or medical countermeasures. The guidance document, Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices , is specifically aimed at those IVDs which are intended to simultaneously detect 20 or more pathogens extracted from a single sam...
  • 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...
  • Regulators Grapple With Complexities of Preparing for Nuclear, Chemical Disaster Events

    Back in September 2012, the US Food and Drug Administration (FDA) issued a little-noticed announcement in the Federal Register indicating that it was interested in starting a dialogue with the medical device industry to plan for the type of mass-casualty event-think a dirty bomb, mass explosion or some other chemical-based incident-that could leave thousands of patients, if not more, requiring medical care. The meeting, part of the US Department of Health and Human S...
  • FDA Beefs up Medical Countermeasure Program with new 510(k) Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry regarding the development of In Vitro devices capable of detecting the presence of several types of dangerous pathogens, its latest effort in a long-running strategy to develop medical countermeasures (MCMs). The guidance, released 9 November 2012, specifically addresses the unique needs of conducting clinical trials on such a device. The clinical testing of products used to tr...