Abstract
The United States regulatory authority can be a complicated system to negotiate. The Food and Drug Administration’s (FDA) mandate, responsibilities, and structure will be reviewed. General topics related to drugs, devices, and biologics will be explored. Orphan product development and grant funding will be discussed. Issues of particular interest to new investigators will be raised with specific emphasis on locating needed information and working with the agency throughout the drug/device/biologic development process.
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References
Public Health Service Act, Biological Products.
Federal Register, vol. 57, no. 250. December 29,1992.21 CFR 316. Orphan Drug Regulations: Final Rule.
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© 1996 Springer Science+Business Media New York
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Rarick, L.D. (1996). Understanding the Organization and Function of the FDA. In: Alexander, N.J., Wentz, A.C. (eds) Idea to Product. Serono Symposia USA. Springer, New York, NY. https://doi.org/10.1007/978-1-4612-0743-6_13
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DOI: https://doi.org/10.1007/978-1-4612-0743-6_13
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4612-6889-5
Online ISBN: 978-1-4612-0743-6
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