"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
|
| 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- New Drug Approval
- Approval, New Drug
- Approvals, New Drug
- Drug Approval, New
- Drug Approvals, New
- New Drug Approvals
|
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 |
|---|
| 1995 | 0 | 1 | 1 |
| 2003 | 1 | 1 | 2 |
| 2005 | 0 | 1 | 1 |
| 2006 | 1 | 0 | 1 |
| 2007 | 0 | 1 | 1 |
| 2008 | 0 | 1 | 1 |
| 2009 | 2 | 1 | 3 |
| 2010 | 0 | 2 | 2 |
| 2012 | 0 | 2 | 2 |
| 2014 | 2 | 1 | 3 |
| 2015 | 1 | 1 | 2 |
| 2016 | 3 | 3 | 6 |
| 2017 | 2 | 1 | 3 |
| 2018 | 1 | 1 | 2 |
| 2019 | 0 | 3 | 3 |
| 2020 | 1 | 1 | 2 |
| 2022 | 2 | 1 | 3 |
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click here.
Below are the most recent publications written about "Drug Approval" by people in Profiles.
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Medicare Spending on Drugs With Accelerated Approval. Ann Intern Med. 2022 07; 175(7):938-944.
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Demographic Disparities in the Federal Drug Approval Process for Allergic Rhinitis Medications. Laryngoscope. 2023 Apr; 133(4):755-763.
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Single-arm clinical trials that supported FDA accelerated approvals have modest effect sizes and were at high risk of bias. J Clin Epidemiol. 2022 08; 148:193-195.
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Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions. Lancet Oncol. 2020 12; 21(12):e575-e588.
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Age-Adjusted D-dimer Cutoffs: A Warning From the Laboratory. Ann Emerg Med. 2020 06; 75(6):783-784.
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A Clinical Overview of Off-label Use of Gabapentinoid Drugs. JAMA Intern Med. 2019 05 01; 179(5):695-701.
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Major hemorrhage in chronic lymphocytic leukemia patients in the US Veterans Health Administration system in the pre-ibrutinib era: Incidence and risk factors. Cancer Med. 2019 05; 8(5):2233-2240.
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Biosimilar Filgrastim Use in the United States vs the European Union and Japan-Why Does It Lag Behind and What Can Be Done? JAMA Oncol. 2019 03 01; 5(3):297-298.
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Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court's Recent Rulings do not Solve Fundamental Barriers to Competition. Drugs. 2018 Nov; 78(17):1777-1781.
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First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF. Am Heart J. 2018 10; 204:139-150.