ABSTRACT
The regulations issued by the US Food and Drug Administration (FDA) several years later as a means to implement the substantial changes in the act were written in a style considered almost unintelligible by those involved in pharmaceutical manufacturing, research, and marketing. The Drug Regulatory Affairs (DRA) group, therefore, reviews the text of all such documents before release and maintains a permanent file of all approved labeling and advertising. Face-to-face meetings with regulatory agency representatives are important in the drug development process. The labeling and advertising of prescription drugs are subject to extensive and detailed regulations. The DRA group, therefore, reviews the text of all such documents before release and maintains a permanent file of all approved labeling and advertising. New drug development and regulation by the FDA are inseparable in the sense that the latter influences almost all stages of the former.
