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Our Health Care Group explains how emergency use authorizations (EUAs) have been issued during the current public health emergency and the benefits and limitations of offering a test pursuant to an EUA and provides practical advice for test developers preparing for the end of the public emergency.
When does an EUA declaration terminate?
EUAs for diagnostics to detect SARS-CoV-2
What happens when the EUA declaration expires?
Since the start of the coronavirus pandemic, the Food and Drug Administration (FDA) has issued almost 400 emergency use authorizations (EUAs) for molecular diagnostic tests, antibody tests, and antigen tests combined. As life returns to something approximating “normal,” many are wondering what happens to tests offered pursuant to EUAs once the public health emergency is terminated.
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Jason S. Madden is a Healthcare attorney at Proskauer Law Firm, specializing in regulatory, transactional and litigation matters, including fraud and abuse compliance.
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Peter Eggers is a corporate attorney at Proskauer Rose law firm in the health care group, in mergers and acquisitions, joint ventures, professional services arrangements and general business planning & health care fraud and abuse, licensure and enrollment.