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Guidance Documents/Guidance-Document/Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization

Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 21, 2023

December 21, 2023

Center for Drug Evaluation and Research

0146d188-0350-4f83-b103-4193b8be1e41

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