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# Covid-19 Monoclonal Antibody EUA Guidance
- URL: https://www.fdaweb.com/covid-19-monoclonal-antibody-eua-guidance/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:18:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156052

FDA has published an immediately effective guidance, *Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization*, with recommendations for sponsors on developing monoclonal antibody products intended to prevent or treat Covid-19, including recommendations on addressing the impact of emerging variants. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-monoclonal-antibody-products-targeting-sars-cov-2-emergency-use-authorization?ref=fdaweb.com) says that while circumstances have improved, SARS-CoV-2 remains in broad circulation throughout the U.S.

“FDA is publishing this guidance to provide its current recommendations on the data and information that may be used to support a request for an emergency use authorization … for a monoclonal antibody product for the prevention or treatment of Covid-19,” the guidance says. The guidance is intended to be effective only for the duration of the 3/27/2020 declaration of the HHS secretary that circumstances exist justifying the authorization of emergency use of drugs and biological products during the Covid-19 pandemic.