miércoles, 28 de febrero de 2018

Medical countermeasure funding opportunities | Quick concussion blood test | Rapid flu test facts

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update

FDA funding opportunity: FDA is seeking 
research & development to support regulatory science & innovation, including tools to support medical countermeasure (MCM) development and evaluation, and improve, ensure, and secure the MCM supply chain. Includes an image of U.S. Public Health Service officers celebrating as a Liberian man adds his handprint to a “survivors’ wall” during the West Africa Ebola outbreak in 2014-2015.

FDA funding opportunity
Broad Agency Announcement (BAA) to support regulatory science and innovation
In February 2018, FDA revised its BAA for research and development to support regulatory science and innovation. Medical countermeasure (MCM)-related research submissions are encouraged under area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health Security.

The current BAA announcement will remain open until further notice, but proposers are encouraged to submit white papers by March 30, 2018 for current fiscal year awards.

Related links: 

    Image: U.S. Public Health Service officers celebrate as a Liberian man adds his handprint to a “survivors’ wall.” Each patient who overcame Ebola after treatment at the USPHS mobile hospital outside Monrovia was given a set of clothes and essentials and invited to mark their recovery with a handprint. (Photo: FDA) An FDA BAA project conducted by Stanford University, with U.S. and international collaborations, will help the global scientific community better understand the course of Ebola and Zika virus infections--an important factor in finding new treatments.

    Quick concussion blood test

    FDA worked closely with the Department of Defense to permit marketing of a quick concussion blood test for adults that can be used by both the American public and U.S. laboratories at home and abroad servicing our Nation’s military personnel. 
    Millions of traumatic brain injury (TBI)-related cases annually. 75% are asssesed as mild TBI (mTBI) = concussion. New quick blood test will likely reduce need for CT scans.

    Related links:

    Rapid influenza tests
    With higher performance standards, FDA helps lower misdiagnoses with antigen-based rapid flu tests during this year’s flu season. Fact sheet (PDF, 112 KB)
    CLIA-Waived Rapid Flu Test Facts - Higher performance standards, to help lower misdiagnoses with antigen-based tests; No nationwide shortage, with 13 
rapid flu tests available showing acceptable clinical performance; Testing not required for treatment, CDC says test results not required for medication - look at signs/symptoms

    Also in flu news, FDA Commissioner Scott Gottlieb, MD, made a statement on FDA’s ongoing efforts to help improve effectiveness of influenza vaccines. FDA is collaborating with the Centers for Medicare and Medicaid Services (CMS) to use a large database that includes details of the flu vaccines administered to four million individuals along with whether they were hospitalized for influenza or treated with antiviral medications for influenza-like illness. This work, which is still underway, will try to better understand why overall effectiveness with both the cell-based and egg-based vaccines was less than optimal. (February 26, 2018)

    Information for industry
    More: MCM-Related Guidance by Date
    In case you missed it

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