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 ). Finally, the policy emphasizes the importance of validation data, and states that FDA is providing EUA templates. academic medical center laboratories).
Let's personalize your content