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U.S. Department of Health and Human Services

Drugs

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CDER Director's Mailbag: Answered Questions

CDER Director's Mailbag

2014


February 10: What is the new drug application?

The regulation and control of new drugs in the United States is based on the new drug application (NDA). The NDA is a regulatory document submitted by the sponsor to FDA as a formal request for marketing approval. The NDA ... more