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U.S. Department of Health and Human Services

About FDA

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Presentations 2005/2006

2006

  • Justice, R, M.D. Dasatinib for CML: Bench to ODAC [PDF]. American Society of Clinical Oncology Annual Meeting, 2006
  • Mann, BS, Kane, R, Brave, M, Ryan, Q, Hazarika, M, Rock, E, Senderowicz, A, Dagher, R, Johnson, J, Justice, R, Pazdur, R. An Analysis of Deficiencies Identified During Investigational New Drug (IND) Application Reviews by the Division of Drug Oncology Products (DDOP) of the US FDA. Abstract 6052. Journal of Clinical Oncology. Volume 24, No 18S, 313s. American Society of Clinical Oncology Annual Meeting, 2006 Poster Presentation.
  • Justice, R, M.D. How to Get a New Drug Approved by the FDA [PDF]. American Society of Clinical Oncology, 2006 Prostate Cancer Symposium.
  • Division of Medical Imaging and Hematology Products Presentations at the Annual Society of Nuclear Medicine Meeting, June, 2006
  • Rahman, A., Ph.D. Considerations for Integration of CDRH and CDER Regulations - A Case Study: Irinotecan and UGT1A1 [PDF]. FDA Workshop, Rockville, MD, March 16, 2006.
  • Ross, D. M.D. Oncology Biomarkers for Safety and Efficacy [PPT]. International Conference on Drug Development, Austin, TX., Feb., 2006.

2005

  • Kane, R., M.D., FACP. FDA Oncology Drug Approval: Endpoints, Effectiveness, and Approval [PDF]. Pharmaceutical Education and Research Institute.

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