Abstract
The Food and Drug Administration (FDA) plays a crucial role in regulating biotechnology products to ensure their safety and efficacy. This chapter provides a historical overview of the FDA, tracing back to the nineteenth century and the establishment of the U.S. Department of Agriculture. It covers significant events leading to the passage of the Federal Food and Drugs Act of 1906 and the subsequent tragedies that revealed the limitations of the act. The chapter also discusses the Coordinated Framework established in 1986, which governs federal oversight of biotechnology products, and the regulatory agencies involved in the intersection of science with public health. Understanding the history and regulatory landscape of biotechnology is crucial in appreciating the opportunities and risks associated with this rapidly evolving field.
In science the credit goes to the man who convinces the world, not the man to whom the idea occurs first.
Sir Francis Darwin
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Stasi, A. (2023). A Brief History of the Fda and Its Role in Regulating Biotechnology Products. In: Biotechnology Law and Policy. Springer, Singapore. https://doi.org/10.1007/978-981-99-2135-5_2
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DOI: https://doi.org/10.1007/978-981-99-2135-5_2
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