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Classification Categories for Certain Supplements Under BsUFA III August 2023

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides recommendations for applicants and FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements (hereafter referred to as PAS or supplements) submitted to approved applications under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals (refer to Section I.A. of the BsUFA III commitment letter).This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.

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-2023-D-1954.

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