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U.S. Department of Health and Human Services

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Confidentiality of Interim Results in Cardiovascular (CV) Outcomes Safety Trials; Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER; Request for Comments

 Meeting Information

 

 Date August 11, 2014
 Time 8 a.m. to 5 p.m. 
 Individuals who wish to present at the public hearing must register by July 28, 2014. Section II of this document provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until October 11, 2014.
 Location

The public hearing will be held at the FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center, (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD 20993. Please note that visitors to the White Oak Campus must enter through Building 1. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm

Please submit electronic comments to http://www.regulations.gov. Submit written comments to the docket by July 28, 2014.
 Registration

Individuals who wish to present at the public hearing must register by July 28, 2014. Section II of this document provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until October 11, 2014. Registrationdisclaimer icon

 
 Contact Indira Hills, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 21, rm. 4508, Silver Spring, MD 20993, 301-796-9686, FAX: 301-796-9907, email: indira.hills@fda.hhs.gov

Supporting Documentation

Alogliptin Disclosure Memo

Alogliptin Science Memo

Federal Register Notice

 

 

 

 Agenda

List of Presenters

List of All Day FDA Panelists  

FDA Panelists Bios 

 

Live Webcast: https://collaboration.fda.gov/dmcidcvtpart15/

 

Adobe links to the recorded live Webcast from the meeting: