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FDA EUA and Literature Update

In a rapidly moving health crisis such as COVID-19, the need for diagnostic and therapeutic options exceeds the ability to analyze and adapt data from prior experiences (e.g., is SARS experience from 2003 directly relevant to diagnosis and treatment of SARS-CoV-2?) or establish, conduct, report, and undergo peer-review for well-considered studies. Use of medication that have shown some premise or promise for success can further be complicated if the medication is FDA-approved, but only for a different indication. The April 22,2020 ACMT webinar focused on the FDA’s Emergency Use Authorization as it applies to both testing modalities and therapeutic agents. The following FAQs provide links to the regulatory authority and mechanisms addressed in the webinar. Some FAQs relating specifically to testing issues are answered on the FAQ page pertaining to the April 29th webinar.

FAQs - FDA EUA and Literature Update

Last updated: May 18, 2020
 What is an Emergency Use Authorization (EUA)? posted on 1:30 PM, July 9, 2020
 What is the difference between Emergency Use Authorization (EUA) and Expanded Access (EA)? posted on 1:31 PM, July 9, 2020
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