New Drug Application

Regulation of therapeutic goods in the United States
Prescription drugs Over-the-counter drugs
Law Federal Food, Drug, and Cosmetic Act CDAPCA Controlled Substances Act Prescription Drug Marketing Act Hatch-Waxman Act exemptions Marihuana Tax Act of 1937
Government agencies Department of Health and Human Services Food and Drug Administration Department of Justice DEA
Process Drug discovery Drug design Drug development New Drug Application Investigational New Drug Clinical trial phases Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
International coordination ICH Uppsala Monitoring Centre WHO CIOMS Single Convention on Narcotic Drugs
Non-governmental organizations National Academy of Medicine RADAR NORML
v t e

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.^[1][2] 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.^[1]

The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug.^[3] Among facts needed for the application are:^[2]

• 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^[4] in certain states.