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U.S. Department of Health and Human Services

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Acute Leukemia Endpoints Meeting Information

The U.S. Food and Drug Administration (FDA) is holding a public workshop on clinical endpoints in acute leukemia. The workshop will discuss clinical trial endpoints that have not been generally accepted but have potential utility for the measurement of clinical benefit or the prediction of clinical benefit with reasonable likelihood for the following disease entities:

  • Pediatric Acute Lymphocytic Leukemia

  • Adult Acute Lymphocytic Leukemia

  • Pediatric Acute Myeloid Leukemia

  • Adult Acute Myeloid Leukemia

  • Acute Leukemia in the Elderly

Issues identified in the workshops will be further discussed before the Oncologic Drugs Advisory Committee (ODAC) and thereafter will be detailed in FDA Guidance Documents.

Date: June 24, 2005, from 8:30 a.m. – 5:00 p.m.

Address: JW Marriott Hotel Pennsylvania Avenue
Salons F and E
1331 Pennsylvania Avenue, NW
Washington, DC 20004
(202) 393-2000

Registration: To register for the workshop, please visit the ASH Web site 

For further information, contact:
The American Society of Hematology (ASH) Government Affairs and Practice Coordinator Stephanie Kart at skart@hematology.org or (202) 776-0544.