ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT Investigative Techniques [E05] Investigative Techniques Drug Development [E05.290] Drug Development Drug Approval [E05.290.250] Drug Approval Compassionate Use Trials [E05.290.250.199] Compassionate Use Trials Investigational New Drug Application [E05.290.250.400] Investigational New Drug Application ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT Investigative Techniques [E05] Investigative Techniques Evaluation Studies as Topic [E05.337] Evaluation Studies as Topic Drug Approval [E05.337.300] Drug Approval Compassionate Use Trials [E05.337.300.199] Compassionate Use Trials Investigational New Drug Application [E05.337.300.400] Investigational New Drug Application SURVEILLANCE IN PUBLIC HEALTH Health Surveillance of Products [VS2] Health Surveillance of Products Drug and Narcotic Control [VS2.002] Drug and Narcotic Control Drug Evaluation [VS2.002.003] Drug Evaluation Drug Approval [VS2.002.003.001] Drug Approval Drug Evaluation, Preclinical [VS2.002.003.001.001] Drug Evaluation, Preclinical Investigational New Drug Application [VS2.002.003.001.002] Investigational New Drug Application Clinical Trials as Topic [VS2.002.003.001.003] Clinical Trials as Topic

Investigational New Drug Application - Preferred

Concept UI	M0026403
Scope note	An application that must be submitted to a regulatory agency (the FDA in the United States) before a drug can be studied in humans. This application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured. (From the "New Medicines in Development" Series produced by the Pharmaceutical Manufacturers Association and published irregularly.)
Preferred term	Investigational New Drug Application
Entry term(s)	Investigational New Drug Applications