Definition

The application submitted to the FDA to obtain approval to market a new drug in the United States. Contains full data on safety, efficacy, CMC, and labeling.

Example

After Phase 3 trials, the sponsor submits an NDA; FDA review leads to approval or complete response letter.

Regulatory source

21 CFR 314, FD&C Act

Common mistakes

Submitting an NDA without adequate CMC or stability data. Not aligning NDA structure with current FDA expectations.

Inspector question

Describe your NDA submission strategy and how you manage review cycles and complete response letters.

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