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(2020)
FDA commissioner: no matter what, only a safe, effective vaccine will get our approval
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Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trialInternational Journal of Antimicrobial Agents, 56
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Anand Shah, P. Marks, Stephen Hahn (2020)
Unwavering Regulatory Safeguards for COVID-19 Vaccines.JAMA
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COVID-19 and the FDA, with Commissioner Stephen Hahn, MD
D. Carpenter (2014)
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N. Lurie, J. Sharfstein, J. Goodman (2020)
The Development of COVID-19 Vaccines: Safeguards Needed.JAMA
Development and licensure of vaccines to prevent COVID-19: guidance for industry
This Viewpoint uses the FDA’s Emergency Use Authorization (EUA) of hydroxychloroquine for COVID-19 treatment to emphasize the costs of premature regulatory authorizations to public health and trust, and proposes the use of advisory committees, requirements for postmarketing surveillance, and adherence to standards of transparency for any future EUAs.
JAMA – American Medical Association
Published: Oct 6, 2020
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