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Wednesday, 07/21/2021 5:38:13 PM

Wednesday, July 21, 2021 5:38:13 PM

Post# of 36558
FDA Transition Plan to “Ordinary Course” Approvals

Even as regulatory oversight gradually reverts to more normal conditions, many EUAs will not be short-lived. Indeed, if past practices are any indication, “emergency conditions” will likely persist for a while yet, as evidenced by the prolonged Zika and Ebola emergencies. Indeed, at a May town hall, the FDA indicated that they do not expect the emergency to be declared over “anytime soon.” It is therefore possible, if not likely, that the COVID-19 state of emergency will persist for several years, and the relatively fast-tracked EUA approval process will remain a viable option.

https://www.jdsupra.com/legalnews/fda-regulatory-approvals-as-the-u-s-2918816/