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    Mary Del Brady Chairman & Ceo, Cvergenx, Inc. Advisor & Founding Ceo, Redpath Integrated Pathology, Inc. Member, Steering Committee, Coalition For 21 Century Medicine

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    Mary Del Brady, Chairman and CEO of CvergenX, Inc. and founding CEO of RedPath Integrated Pathology, Inc., summarizes her views on regulating advanced diagnostic tests. She applauds the FDA's new direction and supports a risk-based and evidence-based oversight framework established through rulemaking. She also supports a mandatory registry of tests using NIH's Genetic Testing Registry and strengthening CLIA while eliminating unnecessary CLIA/FDA overlap. However, new policies must not deter innovation or slow speed-to-market of new solutions. Clinical validity and usefulness should form the basis of FDA guidelines, with help from NIH. Encouraging collaboration between NIH, FDA, CMS, and CDC can help inform policies

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    Mary Del Brady Chairman & Ceo, Cvergenx, Inc. Advisor & Founding Ceo, Redpath Integrated Pathology, Inc. Member, Steering Committee, Coalition For 21 Century Medicine

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    fdablog
    26 views4 pages
    Mary Del Brady, Chairman and CEO of CvergenX, Inc. and founding CEO of RedPath Integrated Pathology, Inc., summarizes her views on regulating advanced diagnostic tests. She applauds the FDA's new direction and supports a risk-based and evidence-based oversight framework established through rulemaking. She also supports a mandatory registry of tests using NIH's Genetic Testing Registry and strengthening CLIA while eliminating unnecessary CLIA/FDA overlap. However, new policies must not deter innovation or slow speed-to-market of new solutions. Clinical validity and usefulness should form the basis of FDA guidelines, with help from NIH. Encouraging collaboration between NIH, FDA, CMS, and CDC can help inform policies

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    FDA-2010-N-0274-0005.1

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    Mary Del Brady, Chairman and CEO of CvergenX, Inc. and founding CEO of RedPath Integrated Pathology, Inc., summarizes her views on regulating advanced diagnostic tests. She applauds the FDA's new direction and supports a risk-based and evidence-based oversight framework established through rulemaking. She also supports a mandatory registry of tests using NIH's Genetic Testing Registry and strengthening CLIA while eliminating unnecessary CLIA/FDA overlap. However, new policies must not deter innovation or slow speed-to-market of new solutions. Clinical validity and usefulness should form the basis of FDA guidelines, with help from NIH. Encouraging collaboration between NIH, FDA, CMS, and CDC can help inform policies

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPS, PDF, TXT or read online from Scribd
    Download as pps, pdf, or txt
    26 views4 pages

    Mary Del Brady Chairman & Ceo, Cvergenx, Inc. Advisor & Founding Ceo, Redpath Integrated Pathology, Inc. Member, Steering Committee, Coalition For 21 Century Medicine

    Uploaded by

    fdablog
    Mary Del Brady, Chairman and CEO of CvergenX, Inc. and founding CEO of RedPath Integrated Pathology, Inc., summarizes her views on regulating advanced diagnostic tests. She applauds the FDA's new direction and supports a risk-based and evidence-based oversight framework established through rulemaking. She also supports a mandatory registry of tests using NIH's Genetic Testing Registry and strengthening CLIA while eliminating unnecessary CLIA/FDA overlap. However, new policies must not deter innovation or slow speed-to-market of new solutions. Clinical validity and usefulness should form the basis of FDA guidelines, with help from NIH. Encouraging collaboration between NIH, FDA, CMS, and CDC can help inform policies

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPS, PDF, TXT or read online from Scribd
    Download as pps, pdf, or txt
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    Mary Del Brady


    Chairman & CEO, CvergenX, Inc.
    Advisor & Founding CEO, RedPath Integrated Pathology, Inc.
    Member, Steering Committee, Coalition for 21st Century Medicine
     "    #$  
      % 
    &   
    V Applaud FDA for new direction
    V Support
    ± Risk-based/Evidence-based oversight with new
    framework established by notice-and-comment
    rulemaking
    ± Registry of tests (support use of NIH¶s developing
    GTR as a mandatory registry under an FDA oversight
    framework)
    ± Strengthening of CLIA and identification/elimination of
    unnecessary CLIA/FDA overlap
    V Caution
    ± New policy must not deter innovation, speed-to-
    market, new solutions
    # '() *% () 
    #   
    V Clear definitions and guidelines for validation are
    helpful to everyone
    V Diagnostics are different - neither devices nor
    pharmaceuticals (although we recognize that
    FDA must operate under existing device
    authority)
    V Clinical validity and usefulness should form basis
    of FDA guidelines with help from NIH
    Strengthen CLIA & Identify/Eliminate
    Unnecessary Overlap with FDA
    Encourage NIH and FDA to work
    collaboratively with the CMS and CDC:
    V To expand and enhance the understanding of
    laboratory science
    V To inform clinical trial design and
    implementation
    V To inform regulatory policy for advanced
    diagnostic tests
    V To avoid duplicative requirements

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