0910-AG94 201704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change.

]]> Other Significant Previously Published in The Unified Agenda Long-Term Actions No No 21 CFR 314.70 21 CFR 314.97 21 CFR 314.150 21 CFR 601.12 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 371 42 U.S.C. 262 ... No NPRM 11/13/2013 78 FR 67985 NPRM Comment Period Extended 12/27/2013 78 FR 78796 NPRM Comment Period End 01/13/2014 NPRM Comment Period Extended End 03/13/2014 NPRM Comment Period Reopened 02/18/2015 80 FR 8577 NPRM Comment Period Reopened End 04/27/2015 Next Action Undetermined To Be Determined Yes Businesses Undetermined No Yes No Janice Weiner L. Principal Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3475 301 847-8440 janice.weiner@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270, Silver Spring MD 20993-0002