Scientific Publications by FDA Staff

Drug Info J 1993 Oct;27(4):1133-6

Patient Information and Education about Drugs: The FDA Perspective

Scheman CR

Patient information and education is high on the Food and Drug Administration's (FDA) agenda. This paper reviews FDA's role in patient information and education, including a recent campaign to improve communications between health care practitioners and patients. Also covered are the problems and solutions being developed for off-label usage, additional labeling indications, direct-to-consumer-advertising, and adverse events reporting.