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Home » FDA Declining to Assess Some Emergency Use Authorization Requests
FDA Declining to Assess Some Emergency Use Authorization Requests
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The FDA’s Center for Devices and Radiological Health is “increasingly declining to review” Emergency Use Authorization (EUA) requests and is “terminating pending EUAs,” for COVID-19 diagnostic tests, according to Hyman, Phelps & McNamara attorney Jeff Shapiro.
One potential reason, he said, is that a particular EUA is likely not a priority given the number of EUAs.
Another potential reason is that there are now so many COVID-19 tests on the market that one of the conditions for granting an EUA — that there are no such products available — no longer applies, he said.
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