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Open for comment Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2015-N-3326

FDA seeks public input on Biosimilar User Fee Act reauthorization for FY 2028-2032

💬 Comments close in 23 days (Nov 25)

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Timeline

  1. Related document

    Biosimilar User Fee Act; Public Meeting

  2. Related document

    Biosimilar User Fee Act; Public Meeting

  3. Related document

    Biosimilar User Fee Act; Public Meeting; Correction

  4. Related document

    Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments

  5. Related document

    Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments

  6. Related document

    Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments

  7. Proposed / opened

    FDA seeks public input on Biosimilar User Fee Act reauthorization for FY 2028-2032

  8. Related document

    Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments

Briefs in this proceeding

Notable FDA 💬 Comments close in 23 days (Nov 25)

FDA seeks public input on Biosimilar User Fee Act reauthorization for FY 2028-2032

FDA will hold a hybrid public meeting and accept written comments through November 25, 2026, on recommendations to reauthorize the Biosimilar User Fee Act before its current authority expires in September 2027. The Food and Drug Administration (FDA) announced a hybrid public meeting to discuss...

Sources

Health and Human Services Department, Food and Drug Administration · Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments · Sep 25