 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 this website 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 |
|---|
| 1998 | 1 | 0 | 1 | | 2000 | 0 | 1 | 1 | | 2006 | 2 | 2 | 4 | | 2008 | 2 | 1 | 3 | | 2009 | 3 | 0 | 3 | | 2011 | 1 | 0 | 1 | | 2012 | 2 | 5 | 7 | | 2014 | 0 | 2 | 2 | | 2015 | 2 | 5 | 7 | | 2016 | 0 | 1 | 1 | | 2017 | 0 | 3 | 3 | | 2018 | 1 | 6 | 7 | | 2019 | 5 | 3 | 8 | | 2020 | 0 | 3 | 3 | | 2021 | 1 | 8 | 9 | | 2022 | 0 | 1 | 1 | | 2023 | 0 | 1 | 1 |
To return to the timeline, click here.
Below are the most recent publications written about "Drug Approval" by people in Profiles.
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Costa E, Girotti S, van den Ham HA, Cipolli M, van der Ent CK, Taylor-Cousar JL, Leufkens HGM. Traits, trends and hits of orphan drug designations in cystic fibrosis. J Cyst Fibros. 2023 Sep; 22(5):949-957.
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DiStefano MJ, Alexander GC, Polsky D, Anderson GF. Public opinion regarding U.S. Food and Drug Administration approval of aducanumab and potential policy responses: A nationally representative survey. J Am Geriatr Soc. 2022 06; 70(6):1685-1694.
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Woodworth KR, Moulia D, Collins JP, Hadler SC, Jones JM, Reddy SC, Chamberland M, Campos-Outcalt D, Morgan RL, Brooks O, Talbot HK, Lee GM, Bell BP, Daley MF, Mbaeyi S, Dooling K, Oliver SE. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years - United States, November 2021. MMWR Morb Mortal Wkly Rep. 2021 Nov 12; 70(45):1579-1583.
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Mbaeyi S, Oliver SE, Collins JP, Godfrey M, Goswami ND, Hadler SC, Jones J, Moline H, Moulia D, Reddy S, Schmit K, Wallace M, Chamberland M, Campos-Outcalt D, Morgan RL, Bell BP, Brooks O, Kotton C, Talbot HK, Lee G, Daley MF, Dooling K. The Advisory Committee on Immunization Practices' Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines - United States, 2021. MMWR Morb Mortal Wkly Rep. 2021 Nov 05; 70(44):1545-1552.
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Petersen BM, Ulmer SA, Rhodes ER, Gutierrez-Gonzalez MF, Dekosky BJ, Sprenger KG, Whitehead TA. Regulatory Approved Monoclonal Antibodies Contain Framework Mutations Predicted From Human Antibody Repertoires. Front Immunol. 2021; 12:728694.
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Dooling K, Gargano JW, Moulia D, Wallace M, Rosenblum HG, Blain AE, Hadler SC, Plumb ID, Moline H, Gerstein J, Collins JP, Godfrey M, Campos-Outcalt D, Morgan RL, Brooks O, Talbot HK, Lee GM, Daley MF, Oliver SE. Use of Pfizer-BioNTech COVID-19 Vaccine in Persons Aged =16 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, September 2021. MMWR Morb Mortal Wkly Rep. 2021 Sep 24; 70(38):1344-1348.
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Rosenblum HG, Hadler SC, Moulia D, Shimabukuro TT, Su JR, Tepper NK, Ess KC, Woo EJ, Mba-Jonas A, Alimchandani M, Nair N, Klein NP, Hanson KE, Markowitz LE, Wharton M, McNally VV, Romero JR, Talbot HK, Lee GM, Daley MF, Mbaeyi SA, Oliver SE. Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021. MMWR Morb Mortal Wkly Rep. 2021 Aug 13; 70(32):1094-1099.
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Cohen MS, Nirula A, Mulligan MJ, Novak RM, Marovich M, Yen C, Stemer A, Mayer SM, Wohl D, Brengle B, Montague BT, Frank I, McCulloh RJ, Fichtenbaum CJ, Lipson B, Gabra N, Ramirez JA, Thai C, Chege W, Gomez Lorenzo MM, Sista N, Farrior J, Clement ME, Brown ER, Custer KL, Van Naarden J, Adams AC, Schade AE, Dabora MC, Knorr J, Price KL, Sabo J, Tuttle JL, Klekotka P, Shen L, Skovronsky DM. Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial. JAMA. 2021 07 06; 326(1):46-55.
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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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Wallace M, Woodworth KR, Gargano JW, Scobie HM, Blain AE, Moulia D, Chamberland M, Reisman N, Hadler SC, MacNeil JR, Campos-Outcalt D, Morgan RL, Daley MF, Romero JR, Talbot HK, Lee GM, Bell BP, Oliver SE. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years - United States, May 2021. MMWR Morb Mortal Wkly Rep. 2021 May 21; 70(20):749-752.
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