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Notice Nearby copied this notice onto the public register from Federal Register. It is not a paid Notice Nearby publication, not an Affidavit of Publication, and not a Placement Certificate. Original: https://www.federalregister.gov/documents/2026/10/13/2026-20817/postapproval-manufacturing-changes-to-biosimilar-and-interchangeable-biosimilar-products-questions.

  1. The notice titled Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability, publication number NN-2026-10240, was copied onto the Notice Nearby public register from a public government source. It is not a paid Notice Nearby placement.
  2. First public: Oct 13, 2026, 7:00 AM PDT. Last date: October 12, 2027. No Notice Nearby fee.
  3. Register URL: https://noticenearby.com/notices/ingest-dbe6e5db423c8e5b
  4. SHA-256:584ba8c4 ad3dcd71 d9624bba 0e720504 b98073f5 df6ea382 0ca3f1f2 c7ab0de8

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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 This guidance finalizes the draft guidance of the same title issued on July 23, 2024.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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