Investigational New Drug Application
"Investigational New Drug Application" is a descriptor in the National Library of Medicine's controlled vocabulary thesaurus,
MeSH (Medical Subject Headings). Descriptors are arranged in a hierarchical structure,
which enables searching at various levels of specificity.
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.)
Below are MeSH descriptors whose meaning is more general than "Investigational New Drug Application".
Below are MeSH descriptors whose meaning is more specific than "Investigational New Drug Application".
This graph shows the total number of publications written about "Investigational New Drug Application" by people in Harvard Catalyst Profiles by year, and whether "Investigational New Drug Application" was a major or minor topic of these publication.
To see the data from this visualization as text,
click here.
| Year | Major Topic | Minor Topic | Total |
|---|
| 1995 | 0 | 1 | 1 |
| 2005 | 0 | 1 | 1 |
| 2013 | 1 | 0 | 1 |
| 2014 | 2 | 0 | 2 |
| 2015 | 0 | 1 | 1 |
| 2018 | 0 | 1 | 1 |
Below are the most recent publications written about "Investigational New Drug Application" by people in Profiles.
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The FDA Breakthrough-Drug Designation - Four Years of Experience. N Engl J Med. 2018 04 12; 378(15):1444-1453.
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The Food and Drug Administration and pragmatic clinical trials of marketed medical products. Clin Trials. 2015 Oct; 12(5):511-9.
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Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs. Health Aff (Millwood). 2015 Apr; 34(4):681-8.
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New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 07 03; 371(1):89-90.
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New FDA breakthrough-drug category--implications for patients. N Engl J Med. 2014 Mar 27; 370(13):1252-8.
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Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. JAMA. 2014 Jan 22-29; 311(4):378-84.
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What is the value of a food and drug administration investigational new drug application for fecal microbiota transplantation to treat Clostridium difficile Infection? Clin Gastroenterol Hepatol. 2014 Feb; 12(2):289-91.
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Barriers to clinical translation with diagnostic drugs. J Nucl Med. 2013 Mar; 54(3):329-32.
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Health research oversight in Africa. Acta Trop. 2009 Nov; 112 Suppl 1:S63-70.
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The use of imaging in the early development of neuropharmacological drugs: a survey of approved NDAs. Clin Pharmacol Ther. 2008 Jul; 84(1):69-74.