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Utilizing 505(b)(2) to Accelerate Drug Development Plans
Session Chair(s)
Ken Phelps
, Camargo Pharmaceutical Services, United States
Taking Full Advantage of the 505(b)(2) NDA Pathway
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)
Ken Phelps
, Camargo Pharmaceutical Services, United States
Utilizing 505(b)(2) in Clinical Bridging Studies
Jeff Antos
Vice President, The Weinberg Group Inc., United States
Taking Full Advantage of the 505(b)(2) NDA Pathway
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