# FDA Gastrointestinal Drugs Advisory Committee Meeting Announcements



## Jeffrey Roberts (Apr 15, 1987)

November 16, 2011: Gastrointestinal Drugs Advisory Committee Meeting Announcement Center	Date	Time	LocationCDER	November 16, 2011 8:00 a.m. to 5:00 p.m. Hilton Inn Washington/College ParkThe BallroomsBaltimore Ave.,College Park, MarylandAgendaThe committee will discuss the design of clinical trials to evaluate the safety, efficacy and durability of response with repeat treatment cycles of XIFAXAN (rifaximin) by Salix Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea.Meeting MaterialsFDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.Background Material:2011 Meeting Materials, Gastrointestinal Drugs Advisory CommitteePublic Participation InformationInterested persons may present data, information, or views, orally or in writing, on issues pending before the committee.Written submissions may be made to the contact person on or before November 1, 2011.Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m on November 16, 2011. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 24, 2011.Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 25, 2011.Webcast InformationCDER will not be providing a webcast of the November 16, 2011 Gastrointestinal Drugs Advisory Committee meeting.Contact InformationKristine T. Khuc, Pharm.D.Center for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire AvenueWO31-2417Silver Spring, MD 20993-0002Phone: 301-796-9001Fax: 301-847-8533E-mail: [email protected] Advisory Committee Information Line1-800-741-8138 (301-443-0572 in the Washington DC area)(3014430572 in the Washington DC area) -follow the prompts to the desired center or product areaPlease call the Information Line for up-to-date information on this meeting.A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristine T. Khuc at (301) 796-9001 at least 7 days in advance of the meeting.FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).


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## Jeffrey Roberts (Apr 15, 1987)

November 17, 2011: Gastrointestinal Drugs Advisory Committee Meeting Announcement Center	Date	Time	LocationCDER	November 17, 2011 8:00 a.m. to 5:00 p.m. Hilton Inn Washington DC/College ParkThe Ballrooms10000 Baltimore AvenueCollege Park, MarylandAgendaThe committee will provide recommendations to the Agency on the design and size of premarketing cardiovascular safety development programs necessary to support approval of products in the class of serotonin (5-hydroxytryptamine) receptor 4 (5HT4) agonists for the proposed indications of chronic idiopathic (of unknown cause) constipation (CIC), constipation predominant irritable bowel syndrome (IBS-C), gastroparesis, and gastroesophageal reflux disease that does not respond to a proton pump inhibitor.Meeting MaterialsFDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.Background Material:2011 Meeting Materials, Gastrointestinal Drugs Advisory CommitteePublic Participation InformationInterested persons may present data, information, or views, orally or in writing, on issues pending before the committee.Written submissions may be made to the contact person on or before November 2, 2011.Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m., November 17, 2011. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 25, 2011.Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 26, 2011.Webcast InformationCDER will not be providing a webcast of the November 17, 2011 Gastrointestinal Drugs Advisory Committee meetingContact InformationMinh Doan, Pharm.D.Center for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire AvenueWO31-2417Silver Spring, MD 20993-0002Phone: 301-796-9001Fax: 301-847-8533E-mail: [email protected] Advisory Committee Information Line1-800-741-8138 (301-443-0572 in the Washington DC area)(3014430572 in the Washington DC area) -follow the prompts to the desired center or product areaPlease call the Information Line for up-to-date information on this meeting.A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Minh Doan at (301) 796-9001 at least 7 days in advance of the meeting.FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).


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