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Examining FDA’s Generic Drug and Biosimilar User Fee Programs

Thursday, March 2, 2017 - 10:00am
Location: 
2123 Rayburn
Examining FDA’s Generic Drug and Biosimilar User Fee Programs
Subcommittees: 

Witnesses

Mr. Allan Coukell
Senior Director, The Pew Charitable Trusts, Health Programs

Mr. David Gaugh
Senior Vice President of Sciences and Regulatory Sciences, Association for Accessible Medicines

Ms. Kay Holcombe
Senior Vice President of Science Policy, Biotechnology Industry Organization

Mr. Bruce A. Leicher
Chair, a Division of the Association for Accessible Medicines, The Biosimilars Council

Ms. Juliana Reed
Immediate Past President, The Biosimilars Forum

Dr. Janet Woodcock M.D.
Director, Food and Drug Administration, Center for Drug Evaluation and Research