The course will focus on drug and well-characterized biological products, and not the regulatory process for devices or generic products, or the abbreviated NDA. This course describes the regulatory background of the NDA and provides an overview of preparing an NDA in CTD format for submission to the FDA.

Key Topics
Overview of FDA.
Roles and responsibilities of FDA.
Regulatory Requirements for drug approval.
Pertinent regulatory processes and forms.
Overview of the CTD format.
Post-approval and marketing regulatory requirements and processes.