Comprehensive Reform of the New Drug Regulatory Process

Abstract

A proposal for a new agency with a new set of mandates to oversee the development of valuable new drugs and the protection of public welfare

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References

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    Mathieu, M. 1990. New Drug Development: A Regulatory Overview. Parexel International Corp., Cambridge, MA.

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    Peck, G.E. 1979. The food and drug laws which affect drag product design, manufacture, and distribution. In Modem Pharmaceutics, G.S. Banker and C.H. Rhodes (eds). New York: Marcel Dekker, p. 735.

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    Spivey, R.N.L., and A.G., Trimble, 1985. New drug applications: How long to gain approval? Clinical Pharm Therap 37: 361.

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Crooke, S. Comprehensive Reform of the New Drug Regulatory Process. Nat Biotechnol 13, 25–29 (1995). https://doi.org/10.1038/nbt0195-25

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