SUB09: The New Drug Application (NDA) for Marketing Approval in the USA

Description

The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.

This module sets out the FDA's requirements for content and formatting of the NDA, details the process by which the agency reviews and approves an application, and describes the applicant's actions in that process.

Mechanisms for expedited drug development and review, including breakthrough therapy designation, are also outlined. The module is up to date with the sixth reauthorisation of the Prescription Drug User Fee Act (PDUFA VI) for fiscal years 2018 to 2022.