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Session Chair(s)
Ken Phelps
Camargo Pharmaceutical Services, United States
Learning Objective : Discuss how 505(b)(2) differs from other regulatory approval pathways; Describe how a detailed development plan utilizing existing literature and data as well as key bridging studies can greatly enhance the success of a pre-IND meeting with the FDA to obtain agreement for streamlined development.
Speaker(s)
Utilizing 505(b)(2) in Clinical Bridging Studies
Ken Phelps
Camargo Pharmaceutical Services, United States
Taking Full Advantage of the 505(b)(2) NDA Pathway
Jeff Antos
The Weinberg Group Inc., United States
Vice President
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