Pharmaceutical Regulatory Affairs: The New Drug Application (NDA) for Marketing Approval in the USA

  • ID: 2863572
  • Training
  • Region: United States
  • Leopink
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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 are also outlined. The module is up to date with the provisions of PDUFA V.


Summarise the content and format requirements for a New Drug Application.

Outline the procedural requirements for an NDA submission to the FDA.

Describe the role of the FDA in the NDA review and approval process.

List the principal provisions available from the FDA for expedited drug development and review, and summarise the criteria that apply to them.
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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.

This session 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 session provides an overview of the fundamental content and format requirements of an NDA for submission to the FDA.

Quality information
The CMC information that must be detailed in the application is described in this session.

Nonclinical information
The nonclinical information that must be provided in an NDA is summarised in this session.

Clinical information
This session 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 session describes priority review, accelerated approval, and fast track development.

Multiple-choice mastery assessment.
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