Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA

Docket Number: FDA-2018-D-1922 Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” This final guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This final guidance for industry revises and replaces the draft guidance of the same name issued in August 2023.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document’s docket number: FDA-2018-D-1922.

• Content current as of:

  07/18/2025

• Regulated Product(s)

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