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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)
Carl C. Peck, MD
Founder, Partner, and Chairman, NDA Partners LLC, United States
Drivers, Antecedents, and Limitations of FDA's Expedited Programs for Serious Conditions
Frank J. Sasinowski, JD, MPH, MS
Director; Board of Directors of the National Organization for Rare Disorders, Hyman Phelps & McNamara, P.C., United States
Dual Tracks of Flexibility in FDA Drug Approval
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