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Author Topic: Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework  (Read 1150 times)

ama

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  • Posts: 1145

http://www.fda.gov/Drugs/NewsEvents/ucm430539.htm

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Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century

On April 20-21, 2015, the Food and Drug Administration (FDA) held a public hearing at its White Oak Campus to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is still seeking written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share. Please refer to the following documents for more information:

    Federal Register Notice
    Submit Comments to the Public Docket

Contact Information

CDERhomeopathicproduct@fda.hhs.gov

Agenda

The agenda (PDF - 105KB) for the April 20-21 public hearing is available.

 
Meeting Transcripts

    Meeting Transcript - April 20, 2015 (PDF - 1.7MB)
    Meeting Transcript - April 21, 2015 (PDF - 1.5MB)

Webcast Recordings

    April 20: Part 1
    April 20: Part 2
    April 20: Part 3
    April 20: Part 4
    April 21: Part 1
    April 21: Part 2
    April 21: Part 3
    April 21: Part 4

FDA Panelists

    Panel Members (PDF - 69KB)

April 20 Presentations

    Adriane Fugh-Berman, Georgetown University Medical Center (PDF - 154KB)
    Michael DeDora, Center for Inquiry (PDF - 430KB)
    Lisa Amerine, Homeopathic Academy of Naturopathic Physicians (PDF - 25KB)
    Amy Rothenberg, American Association of Naturopathic Physicians (PDF - 101KB)
    Bruce H. Shelton, Arizona Homeopathic and Integrative Medical Association (PDF - 195KB)
    Jeannine Ritchot, Health Canada (PDF - 288KB)
    Alison Teitelbaum, National Center for Homeopathy (PDF - 104KB)
    Mark Land, Mark Phillips, Eric Foxman, American Association of Homeopathic Pharmacists (PDF - 297KB)
    Barbara A. Kochanowski, Consumer Healthcare Products Association (PDF - 851KB)
    Luana Colloca, University of Maryland – Baltimore (PDF - 4MB)
    Alyssa Wostrel, Integrative Health Policy Consortium (PDF - 267KB)
    Nancy Peplinsky, Holistic Moms Network (PDF - 124KB)

April 21 Presentations

    Robert C. Dumont, Raby Institute for Integrative Medicine at Northwestern, LLC (PDF - 47KB)
    Will Woodlee, American Herbal Products Association (PDF - 28KB)
    Youngran Chung Northwestern University Feinberg School of Medicine (PDF - 37KB)
    Ronald Boyer, Center for Education and Development of Clinical Homeopathy (PDF - 131KB)
    J.P. Borneman, Gary Yingling, Todd Hoover, Homeopathic Pharmacopoeia Convention of the United States (PDF - 210KB)
    Al Lorman, Law Office of Alvin J. Lorman (PDF - 126KB)
    Terry Cotter, Terra-Medica Inc. (PDF - 132KB)
    Edward D. Pergament, Materia Medica Holding (PDF - 1.6MB)
    Ronald D. Whitmont, Bernardo Merizalde, David Riley, Michelle Dossett, American Institute of Homeopathy (PDF - 396KB)
    David Chipkin, Parmesh Banerji Life Sciences, LLC (PDF - 40KB)
    Yale Martin, Independent Retail Consultant (PDF - 39KB)
    Patrick Gibbons, Emerson Healthcare Group (PDF - 116KB)
    Gary Kracoff, Johnson Compounding and Wellness Center (PDF - 33KB)
    Peter Fisher, Royal London Hospital for Integrated Medicine (PDF - 21KB)
    Daniel L. Michels (PDF - 15KB)

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Page Last Updated: 06/02/2015
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