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December 10, 2020 Jason Varin
With Operation Warp Speed and the Food and Drug Administration (FDA) working to expedite COVID-19 vaccines, treatments and diagnostics, there has become an increased interest in the development process.
University of Minnesota Assistant Professor Jason Varin with the College of Pharmacy addresses how vaccines and drugs are commonly developed and how the FDA can adapt this process to address public health emergencies, such as the current pandemic.
Jason Varin, PharmD
“A standard drug or medical device approval can consume many years from product conception to patient use. While the FDA approval process typically takes up to 10 months, the necessary steps that need to be taken before applying for FDA approval can take up to 10 or more years. These steps include three clinical phases which initially test safety and dosage of the product on dozens of healthy individuals and the later phases focus on efficacy, side effects and adverse reac