federal_register: 2016-18555

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2016-18555 Pediatric Master Protocols; Public Workshop Notice The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop titled, "Pediatric Master Protocols". The objective of the workshop is to discuss regulatory and scientific concerns related to pediatric master protocols and clinical trial design considerations for these protocols. In addition, applications of pediatric master protocols to specific pediatric therapeutic areas will be presented. 2016-08-05 2016 8 https://www.federalregister.gov/documents/2016/08/05/2016-18555/pediatric-master-protocols-public-workshop https://www.govinfo.gov/content/pkg/FR-2016-08-05/pdf/2016-18555.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop titled, "Pediatric Master Protocols". The objective of the workshop is...  

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