Meetings and Workshops

Upcoming

• List of Tentative Meeting Dates for Advisory Committee Meetings
• 2007 FDA Advisory Committee Calendar Meeting information includes center, date, time and location; agenda, presentation procedures, contact persons, and links to the Federal Register notice.

Past

• 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.
    
    
• 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