Healthy Skepticism Library item: 8151

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Landis NT.
Requirements for FDA-approved patient information spelled out in final rule
American Journal of Health System Pharmacy 1999 Jan 15; 56:107-108

Abstract:

A final rule issued by the U.S. Food and Drug Administration (FDA) to take effect on June 1, 1999, that requires manufacturers to provide patient information with prescriptions and products that pose a serious and significant public health concern is discussed, including format and content requirements.