What Is Involved in a New Drug Application?

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


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).


Drug Product Drug Substance Case Report Form Drug Application Environmental Impact Assessment 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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  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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