Guidance: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens

TitleGuidance: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
ToC Doc Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
Docket Number2023-04267
Type Notice
Subject Guidance:
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
Publication Date2023-03-02
Last Updated Date 2023-03-01 08:15:09 -0500
Last Public Inspection2023-03-01
Filed At2023-03-01T08:45:00.000-05:00
PDF 2023-04267_PI.pdf (116678 bytes)
Download TXT / HTML / JSON
Number of Pages 7
Filing Typeregular
AgenciesFood and Drug Administration

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