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Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, 12/12/2008
Presentations
Guidance for Industry Tropical Disease
Priority Review Vouchers.  John C. Andrews, Ph.D., AVI BioPharma, Inc.
ETEC Diarrhea: Global Health Problem for LDCs. Gregory M. Glenn, M.D., Intercell Smart Vaccines
Typhoid Fever Overview. W. James Jackson, Ph.D., Emergent BioSolutions
Presentation of the Infectious Diseases Society of America. Padma Natarajan, MPH, MS, Infectious Diseases Society of America
FDA PRVs – The Potential Can be Realized. Colin Ohrt, M.D., Walter Reed Army Institute of Research
Priority Review Vouchers: Recommendations for an FDA Process to Add to the List of Tropical Diseases. Ben Plumley, Tibotec Research and Development
Additional Diseases to Consider for Priority Review Vouchers. Brad Smith, Ph.D., Brooke Courtney, JD, MPH, University of Pittsburgh Medical Center
Designating Additions to the Current List of Tropical Diseases in the FDA Amendments Act. Wendy Taylor, BIO Ventures for Global Health
Rationale to include Japanese encephalitis among diseases qualifying under FDAAA section 524. Theodore Tsai M.D., MPH, FIDSA, Novartis
FDAAA Section 1102: Priority Review Vouchers Dave Roeder, Office of Antimicrobial Products, CDER
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Additions to Tropical Disease List
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Date created: December 30, 2008 |
