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Steven Zecola Files a Citizen's Petition with the FDA for a New Approach to Address Metastatic Cancer
Date:6/24/2013

e FDA is now accepting online comments from the public on these matters at the above location.

1_/ See, e.g., the National Cancer Institute website at: http://seer.cancer.gov/statfacts/html/all.html.
2_/ See, e.g., “Molecular networks that regulate cancer metastasis”, Spano D, Heck C, De Antonellis P, Christofori G, Zollo M., Semin at Cancer Biol. (2012).
3_/ The National Cancer Institute reports an annual budget for cancer research of about $5 billion. See: http://www.cancer.gov/cancertopics/factsheet/NCI/research-funding/print. The category labeled “metastasis” receives about $400M per year, or about 8% of the total. See: http://fundedresearch.cancer.gov/nciportfolio/.
4_/ See, for example, California Biomedical Research Association, “Fact Sheet: New Drug Development Process”, http://ca-biomed.org/pdf/media-kit/fact-sheets/cbradrugdevelop.pdf (June 2008).
5_/ See, for example, Manhattan Institute for Policy Research, “Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials”, Avik S. A. Roy, Senior Fellow (April 2012).
6_/ See, for example, Dr. Patricia S. Steeg, “Perspective: The Right Trials”, Nature 485, S58-59 (May 2012).
7_/ See, FDA: “Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf (May 2007).

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