Funder
Laura and John Arnold Foundation
Kaiser Permanente Institute for Health Policy
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,Toxicology
Reference49 articles.
1. Food and Drug Administration (2020) Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-clinical-evidence-effectiveness-human-drug-and-biological-products. Accessed 20 May 2021.
2. Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983–2018. JAMA. 2020;323:164–76. https://doi.org/10.1001/jama.2019.20288.
3. Downing NS, Aminawung JA, Shah ND, et al. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012. JAMA. 2014;311:368. https://doi.org/10.1001/jama.2013.282034.
4. Downing NS, Shah ND, Aminawung JA, et al. Postmarket safety events among novel therapeutics approved by the US food and drug administration between 2001 and 2010. JAMA. 2017;317:1854–63. https://doi.org/10.1001/jama.2017.5150.
5. Meyer RJ. Regulatory considerations for determining postmarketing study commitments. Clin Pharmacol Ther. 2007;82:228–30. https://doi.org/10.1038/sj.clpt.6100238.
Cited by
10 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献