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GAO: Prescription Drugs: FDA Guidance and Regulations Related to Data on Elderly Persons in Clinical Drug Trials

WASHINGTON, Oct. 29, 2007-The attached report examines the Food and Drug Administration’s (FDA) guidance and regulations related to (1) drug sponsors’ reporting of data to describe the effects of a proposed drug on elderly persons and (2) FDA medical officers’ review of safety and effectiveness data that drug sponsors provided for elderly persons.

Posted: October 2007