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Meetings and Workshops

Upcoming

Past

  • May 5, 2013. FDA Public Workshop: Clinical Trial Design Issues - Drug & Device Development for Localized Prostate Cancer, San Diego, CA. Meeting information
  • May 6, 2013. FDA Public Workshop: Clinical Trial Design Issues - Development of New Therapies for Non-Muscle Invasive Bladder Cancer, San Diego, CA. Meeting information
  • FDA Public Workshop, Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop, March 22, 2013, FDA White Oak Campus, Bldg. 31, The Great Room, (Rm 1503), Silver Spring, MD. Meeting information
  • Oncologic Drugs Advisory Committee, September 6-7, 2006, Silver Spring, MD. Federal Register notice [TXT] [PDF] The following NDAs will be discussed:
    • NDA 21-874, proposed trade name GENASENSE (oblimersen sodium) Injection, Genta, Inc., proposed indication for the treatment of patients with chronic lymphocytic leukemia in combination  with fludarabine and cyclophosphamide
    • NDA 020-287, FRAGMIN  (dalteparin sodium), Pfizer, Inc., proposed indication for the extended treatment of symptomatic venous thromboembolism (VTE), proximal deep vein thrombosis, and/or pulmonary embolism to reduce the recurrence of  VTE in patients with cancer.
    • NDA 21-660, ABRAXANE (paclitaxel protein-bound particles for injectible suspension) (albumin-bound), Abraxis Bioscience, Inc., including trial design issues for adjuvant treatment of node-positive breast cancer. 
  • Cancer Endpoints
    • Ovarian Cancer Endpoints - FDA and the American Society of Clinical Oncology (ASCO), with co-sponsorship by the American Association for Cancer Research (AACR), April 26, 2006, 8:00 to 5:00 pm, North Bethesda, Maryland. Meeting Information
    • 2003-2006: Meetings for cancer endpoints for primary brain tumors, lung cancer, colorectal cancer, prostate cancer, and acute leukemia. Meeting Information 
  • Past Oncologic Drug Advisory Committee Meetings