Healthy Skepticism Library item: 9180

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

Bolger G.
Communicating drug quality observations
Drug Information Journal 1995; 29:(2):563-569

Abstract:

The U.S. Food and Drug Administration’s (FDA) surveillance of the quality of prescription and nonprescription drug products distributed in the United States is described and a system to obtain voluntary reports, then to evaluate and investigate reported observations, is addressed. The need to quickly communicate this information throughout the agency reviewing divisions, field investigation offices, and to the respective pharmaceutical firms to mitigate any potential public health hazards is stressed.