Pharmaceutical Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA
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Free Trial CoursesOutline:Overview: Provided in this session is information on The course: the scope, the areas not covered, course objectives and US legislative framework. The background and history of NDAs is also included in this session. NDAs: Content and formatting: This session provides an overview of the fundamental content and format requirements of an NDA for submission to the FDA. The four sessions that follow describe requirements for specific sections of the NDA. Chemistry, Manufacturing and Controls (CMC) information. The CMC information that must be detailed in the application is described in this session. Nonclinical information: The nonclinical information that must be detailed in an NDA is described in this session. Clinical and statistical information: This session provides an overview of the content and format requirements of the NDA's clinical data section. Administrative information: The content and format requirements of the index, labeling and application summary are addressed in this session. NDA review and approval process: In this session, the review and approval process, and the FDA's role and actions in it, are described. Accelerated approval options: The FDA offers expedited approval programs for drugs designed to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. These programs are discussed in this session. Key point summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or consolidation of learning points. | Objectives:Students completing this course should be able to: Outline the format and content requirements of a New Drug Application (NDA). Outline the necessary forms required for an NDA application. Review an NDA via a checklist prior to submitting it to the FDA. Summarize the role of the FDA in the NDA review and approval process. Define the programs implemented by the FDA to expedite the drug development and approval process. | |
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