The New Drug Application (NDA) for Marketing Approval in the USA
Learn the requirements to submit a New Drug Application (NDA) for Food and Drug Administration (FDA) approval
Overview
The Food and Drug Administration (FDA) bases the control of medicinal products on the New Drug Application (NDA). The NDA initiates a highly involved drug regulation and approval process, including a rigorous evaluation period before drugs are available for marketing in the US. Learn the key requirements for approval for new drugs in the US.
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 course 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. It is intended primarily for regulatory affairs professionals who are new to the NDA or who seek a refresher course. It will also be of interest to others involved in drug development and/or who interact with the FDA.
Mechanisms for expedited drug development and review, including breakthrough therapy designation, are also outlined. This module is up to date with the seventh reauthorization of the Prescription Drug User Fee Act (PDUFA VII) for fiscal years 2023 through 2027.
The course will cover:
- Overview – Provided in this session is information on the module: the scope, the areas not covered, module objectives and US legislative framework. The background and history of NDAs is also included in this session.
- Introduction – This section defines the NDA, outlines the history of related legislation, describes desirable interaction with the FDA, and introduces the US regulatory framework.
- High-level content and formatting – This section provides an overview of the fundamental content and format requirements of an NDA for submission to the FDA.
- Quality information – The chemistry, manufacturing and controls information that must be detailed in the application is described in this section.
- Nonclinical information – The nonclinical information that must be provided in an NDA is summarized in this section.
- Clinical information – This section sets out the components of the clinical information required in an NDA.
- Administrative information and summaries – The administrative and prescribing information and the summaries required in an NDA are outlined.
- NDA review and approval process – Details of the FDA’s review and approval process are provided.
- Expedited development and review – This section describes priority review, accelerated approval, fast track development, and breakthrough therapy designation.