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FDA Biologics (BLA & Biosimilars)
Original article

Recently Issued Guidance Documents

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Summary

FDA CBER and Cross-Center guidance documents have been recently issued. No specific drug, indication, or material development details are disclosed in this announcement.

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FDACBERguidanceregulatory
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Published by FDA Biologics (BLA & Biosimilars) on September 22, 2026 1:24 PM

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