Healthy Skepticism Library item: 9232

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

Katz LM.
Nonprescription drug development
Drug Information Journal 1994; 28:(2):449-451

Abstract:

The approach taken by the U.S. Food and Drug Administration’s Pilot Drug Evaluation Staff to assess OTC drug switches is described. The 3 types of OTC switches that are described in detail include complete, partial, and lower effective dose, as well as approaches to efficacy, safety, and usage trials. Any switch consideration takes into account a weight-of-the-evidence, case-by-case approach, based on prior knowledge gained from the current marketing experience with the drug, with specific regard to safety and efficacy.