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Clinical research / Pharmacology / Pharmaceuticals policy / Prescription Drug User Fee Act / Biosimilar / Biologic / Pharmaceutical Research and Manufacturers of America / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Food and Drug Administration / Medicine / Pharmaceutical sciences


FDA-Industry Stakeholder Meeting for a 351(k) User Fee Program, July 18, 2011
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Company

MedImmune / Novartis / Teva / HHS Roger McClung ASL Company / /

Facility

MD Building / FDA White Oak Campus / /

IndustryTerm

biosimilar applications / biosimilar products / /

Organization

GPhA / Congress / FDA / Executive Committee / /

Person

Sandi Dennis Andrew Emmett / Philip Ball Sandi Dennis Andrew / Andrew Kish Theresa Mullin Donal / Jeff Francer Steven Giuli Sascha / Amanda Edmonds John Jenkins Chris / Steven Giuli Sascha Haverfield Debbie / Dennis Andrew Emmett Jim / Leah Christl Amanda Edmonds John / Sunanda Bahl Daniel Brounstein Leah / Kathleen Uhl Ann Wion Bob / Vince Suneja Howard Yuwen / Brian Kehoe Andrew Kish Theresa / John Finkbohner Jeff Francer Steven / Chris Joneckis Brian Kehoe Andrew / John Jenkins Chris Joneckis Brian / Laura McKinley Nikhil Mehta John / Andrew Emmett Jim Fenton John Finkbohner Jeff / Sascha Haverfield Debbie Jaskot Laura / Nikhil Mehta John Pakulski / Debbie Jaskot Laura McKinley Nikhil / Ann Wion Bob Yetter / Daniel Brounstein Leah Christl Amanda / Theresa Mullin Donal Parks Rokhsana / /

Position

President / /

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