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Regulatory Compliance

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The Biotech Business Handbook

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Abstract

Significant advances in the biomedical sciences over the past 20 years have led to new medical reagents, drugs, diagnostic devices, and instrumentation. Prior to 1976, the FDA had little interest in regulating medical devices as a group, for they were relatively uncomplicated and easy to use, and presented limited risk to the general population. As such, the FDAhad little more authority to regulate medical devices than that stated in the Federal Food, Drug, and Cosmetic Act of 1938, which was enacted by Congress mainly to protect the public from fraudulent or “quack” devices. However, with the advent of new genetically engineered drugs, antibiotics (including antivirals), computer-controlled surgical and life support equipment, diagnostic procedures such as radioimmunoassay (RIA), and the development of monoclonal antibody technology; it became apparent that the initial laws were inadequate.

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Authors and Affiliations

  1. Advanced Instruments Inc., Norwood, Massachusetts, USA

    Michael G. Pappas PhD

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  1. Michael G. Pappas PhD
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© 1994 Springer Science+Business Media New York

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Pappas, M.G. (1994). Regulatory Compliance. In: The Biotech Business Handbook. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-4612-0293-6_12

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  • DOI: https://doi.org/10.1007/978-1-4612-0293-6_12

  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-4684-7139-7

  • Online ISBN: 978-1-4612-0293-6

  • eBook Packages: Springer Book Archive

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