Sponsor/FDA Meetings (Pre-NDA)

The purpose of a Pre-NDA meeting is to discuss the presentation of data (both paper and electronic) in support of the application. The information provided at the meeting by the sponsor includes:

• A summary of clinical studies to be submitted in the NDA;
• the proposed format for organizing the submission, including methods for presenting the data; and
• other information needed to be discussed.

The meeting is conducted to uncover any major unresolved problems or issues, to identify studies the sponsor is relying on as adequate and well controlled in establishing the effectiveness of the drug, to help the reviewers to become aquainted with the general information to be submitted, and to discuss the presentation of the data in the NDA to facilitate its review.

Once the NDA is filed, a meeting may also occur 90 days after the initial submission of the application in order to discuss issues that are uncovered in the initial review.

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