Meetings and Workshops
- FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop, October 21, 2014, Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD. Meeting information
- List of Tentative Meeting Dates for Advisory Committee Meetings
- FDA Advisory Committee Calendar Meeting information includes center, date, time and location; agenda, presentation procedures, contact persons, and links to the Federal Register notice.
- 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