federal_register: 2014-09695

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2014-09695 Pediatric Clinical Investigator Training Workshop Notice The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics (OPT) and the Center for Drug Evaluation and Research are announcing a 1-day public workshop entitled "Pediatric Clinical Investigator Training." The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. The training course is intended to provide investigators with a clear understanding of some of the challenges of studying products in the pediatric population when the data are intended to be used to support product labeling, an overview of extrapolation as it relates to the pediatric population, a familiarity with FDA processes and timelines that are specific to pediatric product development, and an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population. 2014-04-29 2014 4 https://www.federalregister.gov/documents/2014/04/29/2014-09695/pediatric-clinical-investigator-training-workshop https://www.govinfo.gov/content/pkg/FR-2014-04-29/pdf/2014-09695.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics (OPT) and the Center for Drug Evaluation and Research are announcing a 1-day public workshop entitled "Pediatric Clinical Investigator Training." The purpose of this workshop is...  

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