GUIDANCE DOCUMENT
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry August 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2018-D-1922
- Docket Number:
- FDA-2018-D-1922
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or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 This draft guidance for industry revises and replaces the draft guidance of the same name issued in June 2018.