Abstract
Submission of a new drug application (NDA) involves the compilation of information from many disciplines and sources. This information may be derived from recent work or may entail many lifetimes of development and records. In order to review an NDA completely and in a timely manner, the Food and Drug Administration (FDA) requires submissions to comply with the provisions set forth in the Code of Federal Regulations (1).
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References
CFR 314.50.
CFR 25.31.
CFR 25.24.
CFR 58.
CFR 320.
CFR 56.
CFR 56.104 or 56.105.
CFR 50.
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© 1996 Springer Science+Business Media New York
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Rarick, L.D. (1996). What Is Involved in a New Drug Application?. 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_20
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DOI: https://doi.org/10.1007/978-1-4612-0743-6_20
Publisher Name: Springer, New York, NY
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