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
A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration
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.
^ ab"The Drug Development Process". U.S. Food and Drug Administration. January 4, 2018. Retrieved May 1, 2018.
^ ab"The Drug Development Process. Step 4: FDA Drug Review". U.S. Food and Drug Administration. January 4, 2018. Retrieved May 1, 2018.
^Gad, Shayne Cox (2008). Pharmaceutical Manufacturing Handbook: Production and Processes. John Wiley & Sons. ISBN 9780470259801.
^Commissioner, Office of the. "Public Health Focus - FDA and Marijuana". www.fda.gov. Archived from the original on April 28, 2018. Retrieved April 30, 2018.
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