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- 2021-10-23 发布于浙江
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Assay Development and
Validation for
Immunogenicity Testing of
Therapeutic Protein Products
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to . Submit written
comments to the Division of Dockets Management (
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