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 2013_register executive 2013-08-14 article Notices D09002ee1c7fb1f50 D09002ee1c7fb1fdf 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's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled "Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II)." Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. The purpose of this workshop is to provide a forum to consider issues related to endpoints that can support drug development in the following disease areas: Pediatric and adult inflammatory bowel diseases. 78 FR 49530 https://www.govinfo.gov/app/details/FR-2013-08-14/2013-19684 2013-19684 fr14au13-91 4160-01-P Docket No. FDA-2013-N-0001 https://www.govinfo.gov/app/details/FR-2013-08-14/2013-19684 https://www.govinfo.gov/content/pkg/FR-2013-08-14/html/2013-19684.htm https://www.govinfo.gov/content/pkg/FR-2013-08-14/pdf/2013-19684.pdf 1 p. 49530 49530 78 FR 49530 Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop; Federal Register Vol. 78, Issue NOTICE 2013-19684 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-N-0001 4160-01-P 2013-19684 Notice of public workshop.

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled "Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II)." Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. The purpose of this workshop is to provide a forum to consider issues related to endpoints that can support drug development in the following disease areas: Pediatric and adult inflammatory bowel diseases.

The public workshop will be held on October 21 and 22, 2013, from 8:30 a.m. to 5 p.m. Kevin Bugin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2302, FAX: 301- 796-9905, email: Kevin.Bugin@fda.hhs.gov. Meetings: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics , Kevin.Bugin@fda.hhs.gov http://www.great2.org http://www.regulations.gov Vol. 78, no. 157 Office of the Federal Register, National Archives and Records Administration 2013-08-14 continuing daily deposited born digital 304 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-08-14 P0b002ee185faef62 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr14au13 https://www.govinfo.gov/app/details/FR-2013-08-14 https://www.govinfo.gov/content/pkg/FR-2013-08-14/pdf/FR-2013-08-14.pdf https://www.govinfo.gov/content/pkg/FR-2013-08-14/xml/FR-2013-08-14.xml fdlp 49357 49651 DGPO 2013-08-14 2024-06-03 FR-2013-08-14 machine generated eng FR FR-2013-08-14 78 157