Additional Information (Amendment)

In some cases, an applicant may seek to augment the information provided in the original NDA during the review process. For example, the applicant may submit a new analysis of previously submitted data or information needed to address a deficiency in the drug application.

Any such information provided for an unapproved application is considered an NDA amendment. The submission of a significant amendment may result in an extension of FDA's time line for application review.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.