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HHS/FDA RIN: 0910-AI14 Publication ID: Spring 2025 
Title: Biologics Regulation Modernization 
Abstract:

FDA’s biologics regulations would be updated to clarify existing requirements and procedures related to Biologics License Applications and to promote the goals associated with FDA’s implementation of the abbreviated licensure pathway for biosimilar and interchangeable biological products created by the Biologics Price Competition and Innovation Act of 2009.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Regulatory 
CFR Citation: 21 CFR 601   
Legal Authority: 42 U.S.C. 262    21 U.S.C. 301, et seq.   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/00/2026 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Mustafa Unlu
Director of Policy Staff, Senior Policy Coordinator
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 22, Room 1139,
Silver Spring, MD 20993
Phone:301 796-3396
Email: mustafa.unlu@fda.hhs.gov