{"database": "openregs", "table": "federal_register", "rows": [["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...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2016-10397"], "units": {}, "query_ms": 28.904216014780104, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}