What Is Involved in a New Drug Application?

  • Lisa D. Rarick
Part of the Serono Symposia USA book series (SERONOSYMP)

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).

Keywords

Toxicity Marketing Assure Toxicology Carcinogenicity 

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References

  1. CFR 314.50.Google Scholar
  2. CFR 25.31.Google Scholar
  3. CFR 25.24.Google Scholar
  4. CFR 56.104 or 56.105.Google Scholar

Copyright information

© Springer Science+Business Media New York 1996

Authors and Affiliations

  • Lisa D. Rarick

There are no affiliations available

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