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Clinical research / Dermatologic and Ophthalmic Drugs Advisory Committee / ISTA Pharmaceuticals / Center for Drug Evaluation and Research / Sodium hyaluronate / Food and Drug Administration / Health / Pharmaceutical sciences


SESSION 1: NDA[removed]Bepotastine Besilate Ophthalmic Solution, 1
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City

Colesville / Washington DC / /

Company

Biotechnology Inc. / Medical Affairs ISTA Pharmaceuticals Inc. / Safety Overview / ISTA Pharmaceuticals Inc. / Clinical Research ISTA Pharmaceuticals Inc. / Lantibio Inc. / Medical Monitor ISTA Pharmaceuticals Inc. / Affairs ISTA Pharmaceuticals Inc. / M.D. / PhD / /

Event

FDA Phase / /

Facility

University School / /

IndustryTerm

ophthalmic solution / /

Organization

Dermatologic and Ophthalmic Drugs Advisory Committee / Board of Directors Program Development Advisor Clinical Efficacy and Safety Overview / U.S. Food and Drug Administration / Ophthalmic Drugs Advisory Committee / FDA FOOD AND DRUG ADMINISTRATION / Center for Drug Evaluation / Opening Remarks Michael X. Repka / M.D. Acting Chair Dermatologic and Ophthalmic Drugs Advisory Committee / Clinical Ophthalmology Washington University School / /

Person

Michael X. Repka / Paul T. Tran / X. Repka / Jon Williams / Rhea Lloyd / Silver Spring / Lunch Break / DODAC FDA / Russell Ellison / James Gow / Timothy McNamara / Gregg J. Berdy / Sonal Wadhwa / Roger Vogel / /

Position

Chairman / Director / Vice President / Medical Director / Designated Federal Official / Acting Director / Division of Anti-Infective and Ophthalmic Products / Assistant Professor / Vice President Clinical Research / Consultant / Chief Medical Officer and Program Development Advisor / Medical Officer / Division of Anti-Infective and Ophthalmic Products / Acting Chair / Chair / /

Product

Sodium / Bepotastine / Bepotastine Besilate Ophthalmic Solution / Sodium Hyaluronate Ophthalmic Solution / /

ProgrammingLanguage

DC / /

Technology

Biotechnology / /

SocialTag