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FDA Guidance Eases Some Covid-19 Vaccine Concerns, But Others Remain, MedCity News

July 19, 2020

Kathy Sanzo spoke with MedCity News regarding the Department of Health and Human Services’ Covid-19 vaccine development program, Operation Warp Speed, which aims to develop vaccines against the SARS-CoV-2 in the space of a year rather than the multiple years normally required. A recent Food and Drug Administration (FDA) guidance document addressed concerns from some of the potential for the life sciences industry to cut corners during the accelerated development process. “The FDA has taken, I think, quite a conservative approach to indicating to industry what the expectations are for full approval of a vaccine,” Kathy said in the article. “So it’s not giving industry much of a break,” she added.

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