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#	Item
41	CDER Clinical Review Template Add to Reading List Source URL: www.fda.gov Language: English Design of experiments Pharmacology Epidemiology Evaluation methods Prostate cancer Docetaxel Dendreon Immunotherapy Randomized controlled trial Medicine Chemistry Clinical research
42	CMC REVIEW BLA[removed]Sipuleucel-T (Provenge®) Dendreon Corporation Add to Reading List Source URL: www.fda.gov Language: English Validity Science Dendreon Cancer vaccines Validation Apheresis Cell therapy Prostate cancer Verification and validation Biology Medicine Pharmaceutical industry
43	Teleconference Summary - Provenge, December 14, 2006 Add to Reading List Source URL: www.fda.gov Language: English Dendreon Food and Drug Administration Center for Biologics Evaluation and Research TeleCon Medicine Clinical research Pharmaceutical sciences
44	FDA Informal Discussion Points re: Sipuleucel-T Clinical Development Plan - Provenge, May 19, 2007 Add to Reading List Source URL: www.fda.gov Language: English Statistical models Proportional hazards models Food and Drug Administration Dendreon Statistics Survival analysis Regression analysis
45	MEMORANDUM Department of Health and Human Services Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research Add to Reading List Source URL: www.fda.gov Language: English Dendreon Immunotherapy Prostate cancer Leukapheresis Package insert Apheresis Medicine Hematology Transfusion medicine
46	MEDICAL OFFICER’S REVIEW MEMORANDUM Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Dendreon Docetaxel Immunotherapy Clinical trial Nicholas J. Vogelzang Medicine Cancer treatments Prostate cancer
47	Date: June 26, 2007 From: To: Lori Tull, Regulatory Management Staff, OCTGT, HFM – 705 The file, Dendreon STN[removed] Add to Reading List Source URL: www.fda.gov Language: English Clinical research FDA Special Protocol Assessment Center for Biologics Evaluation and Research Dendreon Cancer vaccine FDA Fast Track Development Program Food and Drug Administration Medicine Health
48	Dendreon – sipuleucel-T (Provenge) - BLA STN[removed] Add to Reading List Source URL: www.fda.gov Language: English Redaction Validation Clinical research Pharmaceutical industry Editing
49	Stat NDA Template Draft 2 Add to Reading List Source URL: www.fda.gov Language: English Prostate cancer Dendreon Cancer vaccine End point of clinical trials Randomized controlled trial Immunotherapy Placebo-controlled study Medicine Clinical research Design of experiments
50	Teleconference - Provenge, May 9, 2007 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Dendreon Center for Biologics Evaluation and Research Food and Drug Administration Medicine Clinical research