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Session Chair(s)
Coleen Klasmeier, JD
Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice
Sidley Austin, LLP, United States
Learning Objective : Discuss new FDA initiatives to encourage innovation; Identify techniques for addressing regulatory obstacles commonly associated with attempts to develop innovative products.
Speaker(s)
Drivers, Antecedents, and Limitations of FDA's Expedited Programs for Serious Conditions
Carl C. Peck, MD
NDA Partners LLC, United States
Founder, Partner, and Chairman
Dual Tracks of Flexibility in FDA Drug Approval
Frank J. Sasinowski, JD, MPH, MS
Hyman Phelps & McNamara, P.C., United States
Director; Board of Directors of the National Organization for Rare Disorders
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