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NCCS Policy Comments: Recommending Cancer Survivorship as a Topic for FDA Patient-Focused Drug Development Meetings

December 9, 2014/in Cancer News, Cancer Policy Blog, FDA, NCCS News, Policy Comments NCCS News, Policy Comments /by actualize

Last week, NCCS submitted comments to the U.S. Food and Drug Administration (FDA) regarding the series of patient-focused drug development meetings that have been convened and the list of disease topic meetings scheduled for 2016-2017. In 2013, FDA convened a patient-focused drug development meeting related to lung cancer and has plans to convene a breast cancer meeting in 2015. For 2016-2017, the FDA has identified ovarian cancer and melanoma as possible topics among a list of other disease areas.

While we commend FDA for their efforts to date, we strongly recommend that cancer survivorship be selected as a topic as it meets the criteria that the agency has identified for qualifying as a meeting topic. In addition, the issues identified by cancer survivors and their caregivers would inform therapy development and the regulatory review of new cancer therapies. They may also offer an important perspective regarding assessment of the impact on therapies on quality of life.

Lastly, we recommend that the series of meetings that will consider drug development in specific disease areas be coordinated by, or at least fully involve, the relevant review office. For example, in the case of meetings related to cancer, we propose that the Office of Hematology and Oncology Products assume a key role in organizing the meeting. We believe that this structure would lead to meetings of high quality with strong agendas, ensure that the findings of the meetings inform regulatory activities, and encourage appropriate meeting follow-up.

Tags: Cancer Survivorship, FDA, policy comments
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  • About
    • Our Mission
    • Our History
    • Our Leadership
      • Policy Advisors
    • Employment
    • Partnerships
    • Financial Information
  • Policy
    • Quality Cancer Care
    • Access to Care
    • Health Equity
    • Redefining Functional Status (RFS)
    • 2020 State of Cancer Survivorship Survey
    • Cancer Care Planning and Communications Act (CCPCA)
  • Get Involved
    • What is Advocacy?
    • Cancer Policy and Advocacy Team (CPAT)
    • Elevating Survivorship
    • Survivor Stories
    • Cancerversary
    • State Based Cancer Advocacy
  • Resources
    • COVID-19 Resources for Cancer Survivors
    • Survivorship Checklist
    • Cancer Survival Toolbox
    • Telehealth
    • Publications
      • Talking With Your Doctor
      • Self Advocacy
      • Employment Rights
      • Remaining Hopeful
    • Cancer Convos Podcast
    • Taking Charge of Your Care
    • Care Planning for Cancer Survivors
    • Tools For Care Providers
    • Order Our Resources
  • News
  • Events
    • From Shadows to Life: A Biography of the Cancer Survivorship Movement
    • Ellen L. Stovall Award
      • 2020 Stovall Awards
      • Honorees
      • Sponsors
      • Committees
      • Reception
      • Nominations
    • Cancer Policy Roundtable
      • Fall 2020 Cancer Policy Roundtable
      • Spring 2020 Cancer Policy Roundtable
    • Cancer Policy and Advocacy Team (CPAT) Symposium 2020
    • Webinars
  • Contact Us

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Harmar Brereton, MD

Founder
Northeast Regional Cancer Institute

 

“Perhaps one of the most impactful collaborations in Dr. Brereton’s extraordinary career remains his early work and long friendship with Ellen Stovall. Through him, and in turn through the thousands of lives he has touched, Ellen’s work continues, and her mission lives on.”

—Karen M. Saunders
President, Northeast Regional Cancer Institute