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HHS/FDA RIN: 0910-AI30 Publication ID: Fall 2023 
Title: Amendment to Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications 

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 
CFR Citation: 21 CFR 310.305   
Legal Authority: 21 U.S.C. 353b    21 U.S.C. 355    21 U.S.C. 374    21 U.S.C. 351 to 352   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/00/2024 
Regulatory Flexibility Analysis Required: No  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:
Ayako Sato
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 51, Room 6206, Center for Drug Evaluation and Research,
Silver Spring, MD 20993
Phone:240 402-4191