Analytical, Diagnostic and Therapeutic Techniques, and Equipment

Investigational New Drug Application

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.)

National Library of MedicineMedical Subject Headings2026

Structured Summary

Abstract

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.)

MeSH Record

Classification

Broader headings

Related Concepts

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See Also

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Synonyms

1 entry terms
  • Investigational New Drug Applications

MeSH Record

Aspects Covered

5 allowable subheadings

Indexed with the subheadings economics, history, legislation & jurisprudence, methods, organization & administration.

MeSH Record

Indexing Annotation

U.S. or foreign, but if U.S., new drug "must be submitted to the FDA" before study in humans

MeSH Record

History Note

93

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Previous Indexing

  • Drugs, Investigational (1990-1992)

MeSH Hierarchy

Tree Numbers

  1. E05.290w.250.400
  2. E05.337.300.400

AMA Style

References

  1. National Library of Medicine. Investigational New Drug Application. Medical Subject Headings (MeSH). 2026. Unique ID D017387. http://id.nlm.nih.gov/mesh/2026/D017387
  2. Investigational New Drug Application. In: Wikidata. https://www.wikidata.org/wiki/Q72370160