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U.S. Department of Health and Human Services

About FDA

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Center For Drug Evaluation and Research History

Federal regulation of drugs emerged as early as 1848, under a law that addressed only imported drugs. In 1905 the American Medical Association launched a private, voluntary means of controlling a substantial part of the drug marketplace, a system that remained in place for over a half-century. Drug regulation in FDA has evolved considerably since President Theodore Roosevelt signed the 1906 Pure Food and Drugs Act.