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Answer» What is New Drug Applications mean? The Food and Drug Administration (FDA)'s 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 informationDrug safety and specific effectiveness for its proposed use(s) when used as directedReports on the design, compliance, and conclusions of completed clinical trials by the Institutional Review BoardDrug susceptibility to abuseProposed labeling (package insert) and directions for useExceptions to this process include voter driven initiatives for medical marijuana in certain states. reference
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