Regulatory Counsel

0910-AH58 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Current Good Manufacturing Practice for Positron Emission Tomography Drugs

The Food and Drug Administration proposes to amend its current good manufacturing practice regulations for positron emission tomography (PET) drugs to delete a reference to an outdated United States Pharmacopeia (USP) chapter and to streamline these requirements to make them applicable to the production, quality assurance, holding and distribution of all PET drugs, including investigational and research PET drugs.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 212 21 U.S.C. 321 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 371 21 U.S.C. 374 sec. 121, Pub. L. 105–115, 111 Stat. 2296 ... No NPRM 09/00/2023 No Businesses None No No No No Sungjoon Chi Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-9674 sungjoon.chi@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 6216, Silver Spring MD 20993