FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 Approach
FDA Law
SEPTEMBER 21, 2022
This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). We note that this policy defines an “experienced developer” more narrowly than the COVID-19 policy. academic medical center laboratories).
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