Federal Register: FDA Finalizes Guidance on Postapproval Manufacturing Changes for Biosimilar Products
October 10, 2026
October 10, 2026
WASHINGTON, Oct. 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
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Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing . . .
* * *
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing . . .