Healthy Skepticism Library item: 9394

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

FDA proposes more stringent pediatric-use labeling of prescription drug products.
Clin Pharm. 1993 Jan; 12:(1):6

Abstract:

A proposed ruling by the Food and Drug Administration (FDA) requiring manufacturers of all prescription drug products to revise the pediatric-use section of the drug labeling to include more complete information on use of the drug in pediatric patients and to better characterize the limitations of the available data is presented.

Keywords:
Child Drug Industry/legislation & jurisprudence Drug Labeling/legislation & jurisprudence* Humans Prescriptions, Drug* United States United States Food and Drug Administration/legislation & jurisprudence*