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  1. FDA History

The History of Biologics Regulation

Modern federal oversight of biological products began under the 1902 Biologics Control Act, which the Hygienic Laboratory of the Public Health and Marine Hospital Service carried out. With the creation of the National Institutes of Health from the Hygienic Laboratory, regulatory authority remained at NIH until 1972, when it was transferred to FDA.

In 2002, the Center for Biologics Evaluation and Research celebrated the centennial anniversary of the 1902 Biologics Control Act.  The following materials were created to commemorate the past 100 years of the regulation of biological products:

Resources on the History of Biological Product Regulation

Public Symposium Commemorating 100 Years of Biologics Regulation

Biologics Regulation and Research: The People and Work of Buildings 29 & 29A

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