Healthy Skepticism Library item: 7806

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

Barlas S.
FDA proposed ruling on package inserts
P-and-T 2001; 26:259

Abstract:

A proposed rule by the U.S. Food and Drug Administration (FDA) that would require drug package inserts to contain a highlights section that would precede comprehensive prescribing information and that would require the inserts to be printed in 8-point type rather than the 5- to 7-point type typically used by the pharmaceutical industry and the potential impact of this proposed rule on the pharmaceutical industry are discussed.