Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability

Jurisdiction: Statewide, NH New Hampshire statewide County, NH
Recorded by: Federal RegisterPublic source — not a Notice Nearby paid publication
Placement start: Oct 13, 2026, 7:00 AM PDT
Placement end: October 12, 2027
Publication fee: Sourced listing · no Notice Nearby fee
Run schedule: 1 insertion: October 13, 2026
File / case: 2026-20817
Parties: Health and Human Services Department; Food and Drug Administration
Original source: https://www.federalregister.gov/documents/2026/10/13/2026-20817/postapproval-manufacturing-changes-to-biosimilar-and-interchangeable-biosimilar-products-questionsSourced from 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 or Agency) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act). This guidance finalizes the draft guidance of the same title issued on July 23, 2024. Agency: Health and Human Services Department; Food and Drug Administration. Source: Federal Register Published: 2026-10-13 Original: https://www.federalregister.gov/documents/2026/10/13/2026-20817/postapproval-manufacturing-changes-to-biosimilar-and-interchangeable-biosimilar-products-questions This listing was added to the Notice Nearby public register from a public government source. It is not a Notice Nearby paid publication, affidavit, or placement certificate.

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published · Federal RegisterOct 13, 2026, 7:00 AM PDT

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