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Food and Drug Administration Center for Drug Evaluation and Research Summary Minutes of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting January 12, 2015 Location: The Marriott Inn and Conference Center,
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City

Hyattsville / /

Company

PhD Chief Scientist New England Research Institutes Inc. / APPLICANT PRESENTATIONS Ferring Pharmaceuticals Inc. / Ferring Pharmaceuticals Inc. / PharmD / /

Event

Person Communication and Meetings / FDA Phase / /

Facility

University Conclusion Eric Rovner / Marriott Inn / Urology Medical University of South Carolina Page / Potomac Ballroom / University Blvd. East / College Park Marriott Hotel / University of Maryland University College / /

MedicalCondition

nocturnal polyuria / severe hyponatremia / hyponatremia / concomitant diseases / mild hyponatremia / liver disease / chronic mild hyponatremia / congestive heart failure / pneumonia / intercurrent illness / disease / kidney disease / acute and chronic hyponatremia / /

Organization

Simon Foundation for Continence / Chief Division of Endocrinology / office of Drug Evaluation / Endocrinologic and Metabolic Drugs Advisory Committee / SUNY Downstate Medical School / office of New Drugs / Food and Drug Administration / Cornell / Urology Medical University / Food and Drug Administration Center for Drug Evaluation / Division of Metabolism / Division of Bone / Cornell University / National Association For Continence / Institute for Bladder / Medical University of South Carolina / Metabolic Drugs Advisory Committee / Georgetown University / University of Maryland University College / Information Office / Center for Drug Evaluation and Research / Emory University School of Medicine Patient Reported Outcomes/Quality / /

Person

Jean-Marc Guettier / Toby C. Chai / Daniel Budnitz / Diane M. Biskobing / Roger Beyer / Charles A. Stanley / Remarks Jean-Marc Guettier / William R. Hiatt / Nocturnal Polyuria Roger Wiederhorn / Robert J. Smith / Peter W.F. Wilson / Brendan M. Everett / William Lubas / Safety Vladimir Yankov / Steven G. Gregg / EMDAC FDA / Jonathan Emens / Life Ray Rosen / Martha Nason / Kevin D. McBryde / Mark Hirsch / John Lavelle / Michael A. Carome / Monica Liebert / Brenda Marczi / James D. Neaton / Susan R. Heckbert / Stephanie L. Begansky / Ed J. Hendricks / Shirley Miller / Diana Hallare / Stuart S. Howards / David W. Cooke / Roger Wiederhorn / Nancy Mueller / Robert J. Smith (Chairperson) / Jens Peter Norgaard / Christian Pavlovich / Mads F. Rasmussen / Jerry G. Blaivas / /

Position

Director / Division of Metabolism and Endocrinology Products / President / Vice President US Regulatory Affairs / Medical Officer DMEP / speaker / Federal Officer / Professor of Urology Global Scientific Affairs Ferring Pharmaceuticals Additional Clinical Relevance/Sleep Donald Bliwise / Acting Designated Federal Officer / Chairman / Professor / Chairperson / Medical Officer / Representative / /

Product

CS-41 / /

ProvinceOrState

Maryland / /

PublishedMedium

Endocrinology / /

URL

http /

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