Re-issuing of USFDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA (Biosimilar User Fee Act) Products

Comments are encouraged within 90 days of issuance

The original guidance was issued in 2015 and was then called: “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants”, but was withdrawn in the same year. This guidance was issued new and provides recommendations to industry on formal meetings between the Food and Drug Administration (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 guidance does not apply to meetings associated with the development of products intended for submission in, or with the review of, new drug applications or abbreviated new drug applications under section 505 of the Federal Food, Drug and Cosmetic Act (FD&C Act), biologics license applications (BLAs) under section 351(a) of the Public Health Service Act (PHS Act), or submissions for devices under the FD&C Act. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant (hereafter referred to as requester(s)) following the procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference/videoconference, or written response only (WRO)). This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.

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