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 66 publications over 23 distinct years, with a maximum of 7 publications in 2020

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

Year	Major Topic	Minor Topic	Total
1995	1	0	1
2000	0	2	2
2002	0	2	2
2003	0	3	3
2004	0	1	1
2005	1	0	1
2007	1	3	4
2008	3	0	3
2009	0	2	2
2010	0	3	3
2011	2	1	3
2012	2	2	4
2013	1	4	5
2014	1	2	3
2015	2	3	5
2016	4	1	5
2017	1	3	4
2018	0	1	1
2019	0	3	3
2020	3	4	7
2021	1	1	2
2022	0	1	1
2025	0	1	1

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

Verheij VA, Diecidue RJ, Botman E, Harrington JD, Haga N, Hidalgo-Bravo A, Delai PLR, Madhuri V, Al Mukaddam M, Zhang K, Cho TJ, Morhart R, Keen R, De Cunto CL, Friedman CS, Grunwald Z, Zasloff M, Netelenbos JC, Hsiao E, Kaplan FS, Pignolo RJ, Scott C, Eekhoff EMW. Palovarotene in fibrodysplasia ossificans progressiva: review and perspective. Expert Opin Pharmacother. 2025 Feb; 26(3):291-299.

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Kanapuru B, Fernandes LL, Fashoyin-Aje LA, Baines AC, Bhatnagar V, Ershler R, Gwise T, Kluetz P, Pazdur R, Pulte E, Shen YL, Gormley N. Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials. Blood Adv. 2022 03 22; 6(6):1684-1691.

View in: PubMed
Arondekar B, Duh MS, Bhak RH, DerSarkissian M, Huynh L, Wang K, Wojciehowski J, Wu M, Wornson B, Niyazov A, Demetri GD. Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015-2020. Clin Cancer Res. 2022 01 01; 28(1):27-35.

View in: PubMed
Angelo M, Ward L. Aducanumab Fails to Produce Efficacy Results Yet Obtains US Food and Drug Administration Approval. Popul Health Manag. 2021 12; 24(6):638-639.

View in: PubMed
Goudra B, Singh PM, Lichtenstein GR. Medical, Political, and Economic Considerations for the Use of MAC for Endoscopic Sedation: Big Price, Little Justification? Dig Dis Sci. 2020 09; 65(9):2466-2472.

View in: PubMed
Joynt Maddox KE, Bleser WK, Das SR, Desai NR, Ng-Osorio J, O'Brien E, Psotka MA, Wadhera RK, Weintraub WS, Konig M. Value in Healthcare Initiative: Summary and Key Recommendations. Circ Cardiovasc Qual Outcomes. 2020 07; 13(7):e006612.

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Gopal AD, Wallach JD, Shah SA, Regillo C, Ross JS. On-Label and Off-Label Clinical Studies of FDA-Approved Ophthalmic Therapeutics. Ophthalmology. 2021 02; 128(2):332-334.

View in: PubMed
Hale PM, Ali AK, Buse JB, McCullen MK, Ross DS, Sabol ME, Tuttle RM, Stemhagen A. Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry. Thyroid. 2020 10; 30(10):1397-1398.

View in: PubMed
Mantle JL, Lee KH. NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies. PDA J Pharm Sci Technol. 2020 Sep-Oct; 74(5):497-508.

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Parish LC, Lambert WC. COVID-19, Serendipity, and Strange Interlude: Gloria in Absurdicum with an Apology to Ovid. Skinmed. 2020; 18(3):143-144.

View in: PubMed

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