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Introduction
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Assessing Preclinical Data
Properties of the Study Drug
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Highlights of FDA History

The evolution of the FDA, covered in Module I of this certification program (Historical Perspectives), is embedded with a history of tragedies involving the use and research of drug products. While tragic, these events underscore the absolute necessity of FDA regulations governing clinical research. The FDA regulations around investigational drugs and devices covered in this module were developed with an intention of protection of human subjects in clinical trials.

Recall some of the events that triggered the development of human subject protections processes: