Regulatory Counsel

0910-AI30 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 310.305 21 U.S.C. 353b 21 U.S.C. 355 21 U.S.C. 374 21 U.S.C. 351 to 352 No NPRM 01/00/2024 No Businesses None No No No No Ayako Sato Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-4191 10903 New Hampshire Avenue, Building 51, Room 6206, Center for Drug Evaluation and Research, Silver Spring MD 20993