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FDA Programs to Encourage Innovation: Maximizing the Opportunities and Confronting the Challenges of New Product Development
Session Chair(s)
Coleen Klasmeier, JD
Partner and Global Coordinator, Food, Drug and Medical Device Reg Practice
Sidley Austin, LLP, United States
This forum will address FDA initiatives to foster innovation in the areas of regulatory science, breakthrough therapies, biomarker qualification, and increased efficiency of clinical trials.
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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