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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

8_/ See, FDA: “Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies” fda.gov/downloads/Drugs/.../Guidances/UCM227351.pdf
(December 2012).
9_/ For a discussion of the proper trial design, see Dr. Patricia S. Steeg, “Perspective: The Right Trials”, Nature 485, S58-59 (May 2012).

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