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 2012_register executive 2012-05-31 article Notices D09002ee1c7fcf562 D09002ee1c7fcf5dc 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) is announcing the availability of a guidance for industry entitled "Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment." This guidance is intended to assist the pharmaceutical industry and investigators who are developing drugs for the treatment of irritable bowel syndrome (IBS), specifically the IBS indications for IBS with diarrhea (IBS-D) and IBS with constipation (IBS-C). The guidance describes the evolution of patient-reported outcome (PRO) measures as primary endpoints for IBS clinical trials, and sets forth provisional endpoints and trial design recommendations that sponsors may apply to IBS clinical trials as PRO measurements continue to evolve. The guidance also discusses the future development of IBS PRO instruments. This guidance finalizes the draft guidance published in March 2010. 77 FR 32124 https://www.govinfo.gov/app/details/FR-2012-05-31/2012-13143 2012-13143 fr31my12-59 4160-01-P Docket No. FDA-2012-D-0146 https://www.govinfo.gov/app/details/FR-2012-05-31/2012-13143 https://www.govinfo.gov/content/pkg/FR-2012-05-31/html/2012-13143.htm https://www.govinfo.gov/content/pkg/FR-2012-05-31/pdf/2012-13143.pdf 2 p. 32124 32125 77 FR 32124 Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment; Availability; Federal Register Vol. 77, Issue NOTICE 2012-13143 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-D-0146 4160-01-P 2012-13143 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment." This guidance is intended to assist the pharmaceutical industry and investigators who are developing drugs for the treatment of irritable bowel syndrome (IBS), specifically the IBS indications for IBS with diarrhea (IBS-D) and IBS with constipation (IBS-C). The guidance describes the evolution of patient-reported outcome (PRO) measures as primary endpoints for IBS clinical trials, and sets forth provisional endpoints and trial design recommendations that sponsors may apply to IBS clinical trials as PRO measurements continue to evolve. The guidance also discusses the future development of IBS PRO instruments. This guidance finalizes the draft guidance published in March 2010.

Submit either electronic or written comments on Agency guidances at any time. Ruyi He, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5122, Silver Spring, MD 20993-0002, 301-796-0910. Guidance for Industry; Availability: Irritable Bowel Syndrome Clinical Evaluation of Drugs for Treatment , http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 77, no. 105 Office of the Federal Register, National Archives and Records Administration 2012-05-31 continuing daily deposited born digital 425 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-05-31 P0b002ee18280c82a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr31my12 https://www.govinfo.gov/app/details/FR-2012-05-31 https://www.govinfo.gov/content/pkg/FR-2012-05-31/pdf/FR-2012-05-31.pdf https://www.govinfo.gov/content/pkg/FR-2012-05-31/xml/FR-2012-05-31.xml fdlp 31975 32389 DGPO 2012-05-31 2024-06-03 FR-2012-05-31 machine generated eng FR FR-2012-05-31 77 105