Vaccines, Blood & Biologics
Public Workshop: Animal Models for the Treatment of Acute Radiation Syndrome
September 17, 2008
8:30 a.m. to 5:30 p.m.
September 18, 2008
8:30 a.m. to 1 p.m.
Hilton Hotel, Washington DC North/Gaithersburg
620 Perry Pkwy.
Gaithersburg, MD 20877
Meeting Purpose and Objectives:
The purpose of the public workshop is to discuss issues that should be considered when developing animal models to assist in developing and demonstrating the efficacy of products intended for treatment of ARS. There are no approved medical products with an indication for treatment of ARS. The public workshop will provide the opportunity to explore current research involving animal models for the development of treatments for ARS, and to determine what areas need further research. There will be feature presentations by experts from government, academia, and medicine. The first day of the workshop will include presentations on the effects of radiation and the management of patients with ARS, and a discussion of the application of the animal rule to therapies for ARS. Both days of the workshop will examine the challenges faced when using animal models to mimic radiation exposure scenarios and will include panel discussions that will focus on various animal models and their application to the different syndromes of ARS.
Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.
Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by August 25, 2008. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m.
Center for Biologics Evaluation and Research (HFM-43)
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448
e-mail: CBERTraining@fda.hhs.gov (Subject line: Animal Models for ARS Workshop)
If you need special accommodations due to a disability, please contact Bernadette Kawaley at least 7 days in advance.