FDA Workshop on Clinical Trial
Endpoints in Acute Leukemia
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
http://www.hematology.org/government/ash_fda_workshop.cfm.
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.
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Date created: September 21, 2005 |