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HHS/FDA | RIN: 0910-AG93 | Publication ID: Spring 2018 |
Title: Pediatric Study Plan Requirements for New Drug and Biologics License Applications | |
Abstract:
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. |
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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: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 314.56 21 CFR 314.101 21 CFR 601.23 21 CFR 312.42 | |
Legal Authority: 21 U.S.C. 355c |
Legal Deadline:
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Overall Description of Deadline: Under section 506 of FDASIA, the proposed rule must be promulgated by July 9, 2013. |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Kristiana Brugger Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 51, Room 5252, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-3600 Email: kristiana.brugger@fda.hhs.gov |