New Drug Application
| Regulation of therapeutic goods in the United States |
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Prescription drugs Over-the-counter drugs |
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.
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.