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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