Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration
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[1] R. Porcher,et al. Ethical and Scientific Considerations Regarding the Early Approval and Deployment of a COVID-19 Vaccine , 2020, Annals of Internal Medicine.
[2] J. Ross,et al. Speed, Evidence, and Safety Characteristics of Vaccine Approvals by the US Food and Drug Administration. , 2020, JAMA internal medicine.
[3] S. Joffe,et al. Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research , 2020, Annals of Internal Medicine.
[4] A. Kesselheim,et al. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration , 2017, JAMA.
[5] Harlan M. Krumholz,et al. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. , 2014, JAMA.