Drug Approval

"Drug Approval" 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.

MeSH information

Definition | Details | More General Concepts | Related Concepts | More Specific Concepts

Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.

Descriptor ID	D017277
MeSH Number(s)	E05.337.300 I01.880.604.605.250.250
Concept/Terms	Drug Approval Drug Approval Approval, Drug Approvals, Drug Drug Approvals Food and Drug Administration Drug Approval Drug Approval Process Drug Approval Process Approval Process, Drug Approval Processes, Drug Drug Approval Processes Process, Drug Approval Processes, Drug Approval New Drug Approval Process New Drug Approval Process New Drug Approval New Drug Approval Approval, New Drug Approvals, New Drug Drug Approval, New Drug Approvals, New New Drug Approvals Food and Drug Administration Drug Approval Process Food and Drug Administration Drug Approval Process

Below are MeSH descriptors whose meaning is more general than "Drug Approval".

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E]
Investigative Techniques [E05]
Evaluation Studies as Topic [E05.337]
Drug Approval [E05.337.300]
Anthropology, Education, Sociology and Social Phenomena [I]
Social Sciences [I01]
Sociology [I01.880]
Social Control, Formal [I01.880.604]
Legislation, Drug [I01.880.604.605]
Drug and Narcotic Control [I01.880.604.605.250]
Drug Approval [I01.880.604.605.250.250]

Below are MeSH descriptors whose meaning is related to "Drug Approval".

Below are MeSH descriptors whose meaning is more specific than "Drug Approval".

publications

Timeline | Most Recent

This graph shows the total number of publications written about "Drug Approval" by people in this website by year, and whether "Drug Approval" was a major or minor topic of these publications.

Bar chart showing 24 publications over 14 distinct years, with a maximum of 4 publications in 2018

To see the data from this visualization as text, click here.

Year	Major Topic	Minor Topic	Total
2000	1	0	1
2002	0	1	1
2005	0	1	1
2008	1	0	1
2011	2	0	2
2012	1	1	2
2013	2	0	2
2016	1	1	2
2017	0	2	2
2018	2	2	4
2019	0	1	1
2020	0	1	1
2021	2	1	3
2026	0	1	1

Below are the most recent publications written about "Drug Approval" by people in Profiles.

Lee JK, Lee HN, Agrawal S, Balsamo JA, Clerman A, Denies S, De Groot A, Fry J, Gaudenzio N, Graves AJ, Howard KE, Hwang S, Jawa V, Jin Y, Kelly-Baker L, Knowlton E, Kolenc F, Sivakumar KK, Lee JH, Li Y, Liang L, Liu D, Liu Y, Lionberger R, Luke MC, Manangeeswaran M, Mendoza M, Murphy I, Norcross M, Polli JE, Puig M, Rao Sp N, Rogers H, Schwendeman A, Siegel R, Shubow S, Smith N, Thacker SG, Tourdot S, Yang K, Zhang L, Zhang D, Smith CJ, Pang ES, Verthelyi D. Proceedings of the 2024 FDA-CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products. AAPS J. 2026 Feb 12; 28(2):61.

View in: PubMed
Vishakha S, Navneesh N, Kurmi BD, Gupta GD, Verma SK, Jain A, Patel P. An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021). Anticancer Agents Med Chem. 2024; 24(8):590-626.

View in: PubMed
Khanna D, Lescoat A, Roofeh D, Bernstein EJ, Kazerooni EA, Roth MD, Martinez F, Flaherty KR, Denton CP. Systemic Sclerosis-Associated Interstitial Lung Disease: How to Incorporate Two Food and Drug Administration-Approved Therapies in Clinical Practice. Arthritis Rheumatol. 2022 01; 74(1):13-27.

View in: PubMed
Rothschild AJ. Why Is There No Food and Drug Administration-Approved Medication for Major Depression With Psychotic Features? J Clin Psychopharmacol. 2021 Jul-Aug 01; 41(4):359-361.

View in: PubMed
Weiner MW, Aisen PS, Beckett LA, Green RC, Jagust W, Morris JC, Okonkwo O, Perrin RJ, Petersen RC, Rivera Mindt M, Saykin AJ, Shaw LM, Toga AW, Trojanowski JQ. Editorial: How Will Aducanumab Approval Impact AD Research? J Prev Alzheimers Dis. 2021; 8(4):391-392.

View in: PubMed
Alvarez DF, Wolbink G, Cronenberger C, Orazem J, Kay J. Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States? BioDrugs. 2020 Dec; 34(6):723-732.

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Saphire EO. A Vaccine against Ebola Virus. Cell. 2020 04 02; 181(1):6.

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Kaner RJ, Bajwa EK, El-Amine M, Gorina E, Gupta R, Lazarus HM, Luckhardt TR, Mouded M, Posada K, Richeldi L, Stauffer J, Tutuncu A, Martinez FJ. Design of Idiopathic Pulmonary Fibrosis Clinical Trials in the Era of Approved Therapies. Am J Respir Crit Care Med. 2019 07 15; 200(2):133-139.

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Chari A, Lonial S, Mark TM, Krishnan AY, Stockerl-Goldstein KE, Usmani SZ, Londhe A, Etheredge D, Fleming S, Liu B, Ukropec J, Lin TS, Jagannath S, Nooka AK. Results of an early access treatment protocol of daratumumab in United States patients with relapsed or refractory multiple myeloma. Cancer. 2018 11 15; 124(22):4342-4349.

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Fisher AC, Kamga MH, Agarabi C, Brorson K, Lee SL, Yoon S. The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing. Trends Biotechnol. 2019 03; 37(3):253-267.

View in: PubMed

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