A New Drug Application (NDA) is a regulatory vehicle through which Sponsors formally propose that the FDA approve a new drug for sale and marketing in the USA.

For successful FDA approval, what content and format requirements are necessary to comply with FDA guidelines? How do you plan your submission timetable?

This module provides regulatory professionals with the requirements to complete and submit NDAs for FDA approval.


Who will benefit from this module?
This module is primarily aimed at regulatory professionals who are new to the New Drug Application (NDA) process. It will also benefit professionals in clinical research, data processing, project management and marketing, and whose role involves interaction with the Food and Drug Administration (FDA).