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HHS/FDA RIN: 0910-AI30 Publication ID: 2026 
Title: Amendment to Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications 
Abstract:

FDA is proposing to amend the adverse event reporting regulations for marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application. The proposed amendment will provide clarity to industry regarding when adverse event reports must be submitted to the Agency.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Deregulatory 
CFR Citation: 21 CFR 310.305   
Legal Authority: 21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353b    21 U.S.C. 355    21 U.S.C. 371    21 U.S.C. 374   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/00/2026 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Michael Bernstein
Supervisory Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO Bldg. 51, Rm. 6240, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3478
Email: michael.bernstein@fda.hhs.gov