federal_register: 2016-10397

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2016-10397 Quantitative Assessment of Assumptions To Support Extrapolation of Efficacy in Pediatrics; Public Workshop Notice The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), is announcing a public workshop entitled "Quantitative Assessment of Assumptions to Support Extrapolation of Efficacy in Pediatrics." The objective of the workshop is to discuss quantitative and qualitative approaches for verifying assumptions pertaining to disease and therapeutic response similarity between adults and children. The workshop will also provide a forum for discussion on the use of modeling and simulation for systematic assessment of extrapolation assumptions. 2016-05-04 2016 5 https://www.federalregister.gov/documents/2016/05/04/2016-10397/quantitative-assessment-of-assumptions-to-support-extrapolation-of-efficacy-in-pediatrics-public https://www.govinfo.gov/content/pkg/FR-2016-05-04/pdf/2016-10397.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 (CERSI), is announcing a public workshop entitled "Quantitative Assessment of Assumptions to Support...  

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