United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2015-10-30 article Notices D09002ee1c7f6f1fc D09002ee1c7f6f28e United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled "Clinical Trials--Assessing Safety and Efficacy in Diverse Populations." The purpose of the meeting is to discuss approaches in clinical trial design and subgroup analyses for therapeutic product development and life-cycle management. 80 FR 66909 https://www.govinfo.gov/app/details/FR-2015-10-30/2015-27728 2015-27728 fr30oc15-76 4164-01-P Docket No. FDA-2015-N-3805 https://www.govinfo.gov/app/details/FR-2015-10-30/2015-27728 https://www.govinfo.gov/content/pkg/FR-2015-10-30/html/2015-27728.htm https://www.govinfo.gov/content/pkg/FR-2015-10-30/pdf/2015-27728.pdf 2 p. 66909 66910 80 FR 66909 Clinical Trials-Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments; Federal Register Vol. 80, Issue NOTICE 2015-27728 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2015-12-02 Docket No. FDA-2015-N-3805 4164-01-P 2015-27728 Notice of meeting; request for comments.

The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled "Clinical Trials--Assessing Safety and Efficacy in Diverse Populations." The purpose of the meeting is to discuss approaches in clinical trial design and subgroup analyses for therapeutic product development and life-cycle management.

The meeting will be held on December 2, 2015, from 9 a.m. to 5 p.m. Martin Mendoza, Office of Minority Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2306, Silver Spring, MD 20993-0002, Martin.Mendoza@fda.hhs.gov. Meetings: Clinical TrialsAssessing Safety and Efficacy for Diverse Populations , Jill.Zung@fda.hhs.gov Martin.Mendoza@fda.hhs.gov http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.jhsph.edu/research/centers-and-institutes/center-of-excellence-in-regulatory-science-and-innovation/news-and-events/clinical-trials-assessing-safety-and-efficacy-for-diverse-population.html http://www.regulations.gov http://www.surveymonkey.com/r/ClinicalTrialsWorkshop120215 www.regulations.gov Vol. 80, no. 210 Office of the Federal Register, National Archives and Records Administration 2015-10-30 continuing daily deposited born digital 488 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-10-30 P0b002ee18dd5b396 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr30oc15 https://www.govinfo.gov/app/details/FR-2015-10-30 https://www.govinfo.gov/content/pkg/FR-2015-10-30/pdf/FR-2015-10-30.pdf https://www.govinfo.gov/content/pkg/FR-2015-10-30/xml/FR-2015-10-30.xml fdlp 66781 67259 DGPO 2015-10-30 2024-06-02 FR-2015-10-30 machine generated eng FR FR-2015-10-30 80 210