Nurses' guide to the drug development process and the current regulatory environment.
Health care professionals are frequently asked to answer patients' questions about how medications reach the market and the lengthiness of the process. Misconceptions about the process require nurses to understand how the Food and Drug Administration (FDA) enforces its laws, and how the agency works in the enforcement of its responsibilities. The purpose of this article is to familiarize nurses' with the FDA's history and the drug development process. In addition, nurses need to be familiar with the current environment at the agency and issues that are currently under debate (Franke, 1992).
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D017277:Drug Approval / Q000458:organization & administration*; D004506:Education, Nursing; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration