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HHS Withdraws Policy Concerning Laboratory Developed Tests | FDA Updates Certain COVID-19 Test Policies and Review Prioritization

As the COVID-19 pandemic progressed, the U.S. Food and Drug Administration (FDA) sought to provide timely guidance to the relevant stakeholders to support continuity and response efforts. Notwithstanding, on August 19, 2020,...more

The FDA Revokes EUAs for Decontamination Systems and Non-NIOSH-Approved Respirators (i.e., KN95 Respirators)

Since early last year, the United States Food and Drug Administration (FDA) issued several Emergency Use Authorizations (EUAs) for personal protective equipment (PPE) products to address concerns about their availability...more

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