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# Guide on Biosimilar Product Formal Meetings with FDA
- URL: https://www.fdaweb.com/guide-on-biosimilar-product-formal-meetings-with-fda/
- Published: 2018-06-04T12:00:00.000Z
- Updated: 2026-09-15T00:10:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141591

FDA has made available a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609662.pdf?ref=fdaweb.com) on “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” The document provides recommendations on formal meetings between the agency and sponsors or applicants relating to developing and the review of biosimilar or interchangeable biological products. Formal meetings under the guidance includes any meeting that is requested by a sponsor or applicant and conducted in any format (i.e., face to face, teleconference/videoconference, or written-response only).