 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.
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
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| MeSH Number(s) |
E05.337.300 I01.880.604.605.250.250
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| 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- New Drug Approval
- Approval, New Drug
- Approvals, New Drug
- Drug Approval, New
- Drug Approvals, New
- New Drug Approvals
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Below are MeSH descriptors whose meaning is more general than "Drug Approval".
Below are MeSH descriptors whose meaning is more specific than "Drug Approval".
This graph shows the total number of publications written about "Drug Approval" by people in UAMS Profiles by year, and whether "Drug Approval" was a major or minor topic of these publications.
To see the data from this visualization as text, click here.
| Year | Major Topic | Minor Topic | Total |
|---|
| 2024 | 0 | 1 | 1 | | 2023 | 0 | 1 | 1 | | 2022 | 2 | 0 | 2 | | 2021 | 1 | 2 | 3 | | 2020 | 2 | 3 | 5 | | 2018 | 0 | 1 | 1 | | 2015 | 0 | 1 | 1 | | 2014 | 1 | 1 | 2 | | 2012 | 0 | 1 | 1 | | 2011 | 0 | 2 | 2 | | 2010 | 2 | 0 | 2 | | 2008 | 1 | 0 | 1 | | 2007 | 0 | 2 | 2 | | 2006 | 1 | 1 | 2 | | 2005 | 3 | 5 | 8 | | 2004 | 0 | 1 | 1 | | 2003 | 1 | 1 | 2 | | 2002 | 1 | 1 | 2 |
To return to the timeline, click here.
Below are the most recent publications written about "Drug Approval" by people in Profiles over the past ten years.
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Patel T, Chen C, Al Hadidi S, Kadry Y, Sridhara R, Purcell E, Wisch L, Retzlaff J, Foti M, Pazdur R, Kluetz P, Gao J. Reflections and Roadmaps: Career Development beyond the FDA-AACR Oncology Educational Fellowship. Clin Cancer Res. 2024 Aug 01; 30(15):3144-3146.
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Matthew-Onabanjo AN, Nortey G, Matulewicz RS, Basak R, Culton DA, Weaver KN, Gallagher KK, Tan HJ, Rose TL, Milowsky M, Bjurlin MA. Diversity, equity, and inclusion in genitourinary clinical trials leading to FDA novel drug approval: An assessment of the FDA center for drug evaluation and research drug trials snapshot. Curr Probl Cancer. 2023 06; 47(3):100958.
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Fatoki RA, Koehn K, Kelkar A, Al Hadidi S, Mehra N, Mian H, Landgren O, Kazandjian D, Hoffman J, Sborov DW, Mohyuddin GR. Global Myeloma Trial Participation and Drug Access in the Era of Novel Therapies. JCO Glob Oncol. 2022 08; 8:e2200119.
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Al Hadidi S, Schinke C, Thanendrarajan S, Zangari M, van Rhee F. Enrollment of Black Participants in Pivotal Clinical Trials Supporting US Food and Drug Administration Approval of Chimeric Antigen Receptor-T Cell Therapy for Hematological Malignant Neoplasms. JAMA Netw Open. 2022 04 01; 5(4):e228161.
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Wolf J, Abzug MJ, Wattier RL, Sue PK, Vora SB, Zachariah P, Dulek DE, Waghmare A, Olivero R, Downes KJ, James SH, Pinninti SG, Yarbrough A, Aldrich ML, MacBrayne CE, Soma VL, Grapentine SP, Oliveira CR, Hayes M, Kimberlin DW, Jones SB, Bio LL, Morton TH, Hankins JS, Maron GM, Timberlake K, Young JL, Orscheln RC, Schwenk HT, Goldman DL, Groves HE, Huskins WC, Rajapakse NS, Lamb GS, Tribble AC, Lloyd EC, Hersh AL, Thorell EA, Ratner AJ, Chiotos K, Nakamura MM. Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of Coronavirus Disease 2019 in Children and Adolescents. J Pediatric Infect Dis Soc. 2021 May 28; 10(5):629-634.
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Awidi M, Al Hadidi S. Participation of Black Americans in Cancer Clinical Trials: Current Challenges and Proposed Solutions. JCO Oncol Pract. 2021 05; 17(5):265-271.
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Al Hadidi S, Ramos CA. Level of evidence for FDA drug approvals in pivotal clinical trials of hematological malignancies. Leuk Lymphoma. 2021 06; 62(6):1522-1524.
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Weston S, Coleman CM, Haupt R, Logue J, Matthews K, Li Y, Reyes HM, Weiss SR, Frieman MB. Broad Anti-coronavirus Activity of Food and Drug Administration-Approved Drugs against SARS-CoV-2 In Vitro and SARS-CoV In Vivo. J Virol. 2020 10 14; 94(21).
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Koturbash I, MacKay D. Cannabidiol and Other Cannabinoids: From Toxicology and Pharmacology to the Development of a Regulatory Pathway. J Diet Suppl. 2020; 17(5):487-492.
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Walker LA, Koturbash I, Kingston R, ElSohly MA, Yates CR, Gurley BJ, Khan I. Cannabidiol (CBD) in Dietary Supplements: Perspectives on Science, Safety, and Potential Regulatory Approaches. J Diet Suppl. 2020; 17(5):493-502.
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Stevens D, Claborn MK, Gildon BL, Kessler TL, Walker C. Onasemnogene Abeparvovec-xioi: Gene Therapy for Spinal Muscular Atrophy. Ann Pharmacother. 2020 10; 54(10):1001-1009.
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Atrash S, Bano K, Harrison B, Abdallah AO. CAR-T treatment for hematological malignancies. J Investig Med. 2020 06; 68(5):956-964.
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Lee GR, Maarouf M, Hendricks AJ, Lee DE, Shi VY. Topical probiotics: the unknowns behind their rising popularity. Dermatol Online J. 2019 May 15; 25(5).
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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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Danhof S, Schreder M, Rasche L, Strifler S, Einsele H, Knop S. 'Real-life' experience of preapproval carfilzomib-based therapy in myeloma - analysis of cardiac toxicity and predisposing factors. Eur J Haematol. 2016 Jul; 97(1):25-32.
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