Regulatory Counsel

0910-AG93 201910 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Pediatric Study Plan Requirements for New Drug and Biologics License Applications

FDA is proposing requirements for the content of initial pediatric study plans required to be submitted under the Pediatric Research Equity Act (PREA) which requires sponsors of certain applications to submit a plan for studying their drug/biologic in pediatric patients; a primary factor in the increased ability to provide labeling and other drug information for pediatric patients for many more drug and biological products. Developing drugs for pediatric populations presents unique challenges for drug manufacturers. Although the plans are required to be submitted based on the statutory provision, a regulation is required and will provide clarity, specificity, and direction to sponsors, as well as assist FDA in ensuring compliance, and ultimately help to better advance the study of drugs in pediatric populations to support advancing pediatric indications.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Fully or Partially Exempt 21 CFR 314.56 21 CFR 314.101 21 CFR 601.23 21 CFR 312.42 21 U.S.C. 355c Statutory Final 07/09/2013 Pediatric Study Plans section 506 (title V) FDASIA Under section 506 of FDASIA, the proposed rule must be promulgated by July 9, 2013. No NPRM 09/00/2020 No None No No No No Kristiana Brugger Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3600 kristiana.brugger@fda.hhs.gov Center for Drug Evaluation and Research, WO 51, Room 5252, 10903 New Hampshire Avenue, Silver Spring MD 20993