Guidance Extends FDA COVID-19 Monoclonal Antibody EUA Policy Beyond Pandemic

In a final guidance issued this week, the FDA outlines recommendations for continued development of monoclonal antibody products targeting SARS-CoV-2 to meet emergency needs.

The 14-page guidance, “Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization,” focuses on the data and information that may be used to support a request for emergency use authorization of a drug product to prevent or treat the virus. The guidance, set to be effective immediately, is intended to remain in effect only for the duration of circumstances that exist to justify the authorization of emergency use of COVID-19 drugs.

The updated guidance supersedes the guidance entitled “Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency” issued on Feb. 22, 2021. The Biden administration declared the end of the public health emergency in May.

Read the final guidance here.

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