federal_register: 2017-20106

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2017-20106 Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints; Public Workshop Notice The Food and Drug Administration (FDA) is announcing the following public workshop entitled "FDA-University of Maryland CERSI Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints." The purpose of the public workshop is to address challenges related to the evaluation of products in pediatric heart failure including population to study, endpoints, and extrapolation of adult efficacy data. The workshop will also provide a forum for discussion on the use of registry data, as well as alternative trial designs and statistical methods. 2017-09-21 2017 9 https://www.federalregister.gov/documents/2017/09/21/2017-20106/drug-development-in-pediatric-heart-failure-extrapolation-clinical-trial-design-and-endpoints-public https://www.govinfo.gov/content/pkg/FR-2017-09-21/pdf/2017-20106.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the following public workshop entitled "FDA-University of Maryland CERSI Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints." The purpose of the public...  

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