Abstract
The United States Food and Drug Administration (FDA) has statutory authority over an extremely broad range of products. Administering the Federal Food, Drug, and Cosmetic Act (FFDCA) and parts of the Public Health Service Act, the FDA’s jurisdiction includes human and animal drugs, human biologicals, foods, food additives, medical devices, and cosmetics. The nature of this regulatory power varies with each class of product, e.g., drug companies face an entirely different regulatory scheme compared with cosmetic manufacturers.
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Notes
See generally K. Zoon, “The Impact of New Biotechnology on the Regulation of Drugs and Biologics,” 41 Food Drug Cosmetic Law Journal 429 (1986).
See J. Gibbs and J. Kahan, “Federal Regulation of Food and Food Additive Biotechnology,” 38 Administrative Law Review, 1 (1986)
S. McNamara, “FDA Regulation of Food Substances Produced by New Techniques of Biotechnology,” 42 Food Drug Cosmetic Law Journal 50 (1987)
H. Miller, “The Impact of New Technology on Regulation by the FDA: Recombinant DNA Technology,” 36 Food Drug Cosmetic Law Journal 348, 352 (1981).
For a comparison of the 510(k) notice and premarket approval application, see J. Kahan, “Premarket Approval Versus Premarket Notification: Different Routes to the Same Market,” 39 Food Drug Cosmetic Law Journal 510 (1984)
See also J. Kahan and J. Gibbs, “Food and Drug Administration Regulation of Medical Device Biotechnology, and Food and Food Additive Biotechnology,” 11 Applied Biochemistry and Biotechnology 507 (1985)
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© 1987 Jeffrey N. Gibbs, Iver P. Cooper, Bruce F. Mackler
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Gibbs, J.N., Cooper, I.P., Mackler, B.F. (1987). Food and Drug Administration. In: Biotechnology & the Environment: International Regulation. Palgrave, London. https://doi.org/10.1007/978-1-349-09160-7_7
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DOI: https://doi.org/10.1007/978-1-349-09160-7_7
Publisher Name: Palgrave, London
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