Antigen EUA Templates for Developers of Diagnostic Tests for Monkeypox
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Antigen EUA Templates for Developers of Diagnostic Tests for Monkeypox
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Jason E. B. , On: Nov. 29, 2022, 5:54 p.m.
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Subject: Antigen EUA Templates for Developers of Diagnostic Tests for Monkeypox Content: U.S. Food and Drug Administration sent this bulletin at 11/29/2022 11:39 AM EST
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Monkeypox Update: Antigen EUA Templates for Test Developers
Today, the U.S. Food and Drug Administration (FDA) posted the following templates with recommendations on what to include in Emergency Use Authorization (EUA) requests or Pre-EUA submissions for monkeypox antigen tests.
EUA Summary Template for Developers of Antigen Diagnostic Tests for Monkeypox
EUA Template for Developers of Antigen Diagnostic Tests for Monkeypox
These templates reflect the FDA's current thinking on the data and information that test developers should submit to facilitate the EUA process. The templates provide information and recommendations, and we plan to update them as appropriate as we learn more about monkeypox and gain experience with the EUA process for the various types of monkeypox tests.
The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.
U.S. Food and Drug Administration sent this bulletin at 11/29/2022 11:39 AM EST
If your email program has trouble displaying this email, view as a webpage.
Monkeypox Update: Antigen EUA Templates for Test Developers
Today, the U.S. Food and Drug Administration (FDA) posted the following templates with recommendations on what to include in Emergency Use Authorization (EUA) requests or Pre-EUA submissions for monkeypox antigen tests.
EUA Summary Template for Developers of Antigen Diagnostic Tests for Monkeypox
EUA Template for Developers of Antigen Diagnostic Tests for Monkeypox
These templates reflect the FDA's current thinking on the data and information that test developers should submit to facilitate the EUA process. The templates provide information and recommendations, and we plan to update them as appropriate as we learn more about monkeypox and gain experience with the EUA process for the various types of monkeypox tests.
The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.
