Healthy Skepticism Library item: 9220

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

Specific requirements on content and format of labeling for human prescription drugs; revision of pediatric use subsection in the labeling; final rule
Federal Register 1994 Dec 13; 59:64240-64250

Abstract:

The U.S. Food and Drug Administration (FDA) amendment of the regulations governing the content and format of professional labeling for human prescription drug products to provide for the inclusion of more complete information about the use of a drug in the pediatric population is presented; the final rule recognizes several methods of establishing substantial evidence to support pediatric claims and also requires that if there is no substantial evidence the labeling must state this.