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 2017_register executive 2017-09-06 article Notices D09002ee1c7f10380 D09002ee1c7f10400 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), Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled "CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development." This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. This effort is consistent with FDA's efforts to support the integration of patient experience in drug development programs, including through implementation of the "Patient-Focused Drug Development" provisions of the 21st Century Cures Act (Cures Act). This public workshop will include case studies demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development. 82 FR 42100 https://www.govinfo.gov/app/details/FR-2017-09-06/2017-18810 2017-18810 fr06se17-54 4164-01-P Docket No. FDA-2017-N-0001 https://www.govinfo.gov/app/details/FR-2017-09-06/2017-18810 https://www.govinfo.gov/content/pkg/FR-2017-09-06/html/2017-18810.htm https://www.govinfo.gov/content/pkg/FR-2017-09-06/pdf/2017-18810.pdf 1 p. 42100 42100 82 FR 42100 Food and Drug Administration, Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development; Federal Register Vol. 82, Issue NOTICE 2017-18810 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2017-N-0001 4164-01-P 2017-18810 Notice of public workshop.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled "CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development." This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. This effort is consistent with FDA's efforts to support the integration of patient experience in drug development programs, including through implementation of the "Patient-Focused Drug Development" provisions of the 21st Century Cures Act (Cures Act). This public workshop will include case studies demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development.

The public workshop will be held on October 30, 2017, from 8 a.m. to 5 p.m. Francis Kalush, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5429, PASE-RARE- DISEASES@fda.hhs.gov Meetings: Food and Drug Administration, Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development , PASE-RARE-DISEASES@fda.hhs.gov https://www.fda.gov https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm https://www.fda.gov/Drugs/NewsEvents/ucm565398.htm https://www.regulations.gov Vol. 82, no. 171 Office of the Federal Register, National Archives and Records Administration 2017-09-06 continuing daily deposited born digital 221 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-09-06 P0b002ee196d8d161 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr06se17 https://www.govinfo.gov/app/details/FR-2017-09-06 https://www.govinfo.gov/content/pkg/FR-2017-09-06/pdf/FR-2017-09-06.pdf https://www.govinfo.gov/content/pkg/FR-2017-09-06/xml/FR-2017-09-06.xml fdlp 42021 42232 DGPO 2017-09-06 2024-06-01 FR-2017-09-06 machine generated eng FR FR-2017-09-06 82 171