New Drug Application
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.
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Prescription drugs Over-the-counter drugs |
The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug. Among facts needed for the application are:
- Patent and manufacturing information
- Drug safety and specific effectiveness for its proposed use(s) when used as directed
- Reports on the design, compliance, and conclusions of completed clinical trials by the Institutional Review Board
- Drug susceptibility to abuse
- Proposed labeling (package insert) and directions for use
Exceptions to this process include voter driven initiatives for medical marijuana in certain states.
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