The New Drug Application represents the culmination of years of drug development, presenting the complete body of evidence demonstrating that a new drug is safe and effective for its proposed use. This submission marks the formal request to FDA for permission to market the drug product in the United States. The NDA consolidates all data from preclinical studies, clinical trials, manufacturing process development, and labeling into a comprehensive package that regulatory reviewers evaluate to make an approval decision.

The NDA contains multiple sections organized according to the Common Technical Document format, which has been internationally harmonized across major regulatory regions. Module 1 contains administrative information and prescribing information. Module 2 provides summaries of each technical section. Module 3 details chemistry, manufacturing, and controls. Module 4 presents nonclinical study reports. Module 5 contains clinical study reports and integrated analyses of safety and efficacy. This standardized structure facilitates global development programs and simultaneous submissions to multiple regulatory authorities.

FDA review of an NDA typically requires ten to twelve months for standard review or six months for priority review. The review process involves specialists from multiple disciplines evaluating their respective sections and participating in interdisciplinary discussions. The FDA may issue Complete Response Letters identifying deficiencies that must be addressed before approval, request additional information during review, or convene Advisory Committee meetings for expert input on complex applications. Upon approval, the FDA issues an approval letter authorizing commercial distribution under specified conditions and with approved labeling.