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United States FDA's emergency use authorization of Ebola virus diagnostics: current impact and lessons for the future

Chris A Whitehouse1, Sina Bavari1, Mark D Perkins2

  • 1a 1 Molecular and Translational Sciences Division, US Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, MD, USA.

Expert Review of Molecular Diagnostics
|September 24, 2015
PubMed

Keywords:
Ebolaassaysdiagnosticsfilovirusesregulationviral outbreaks

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Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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Investigation of Disease Outbreaks

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