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FDA Addresses Common Deficiencies in New Drug Applications As part of FDA's recent mandate to be more transparent in their processes and procedures, three FDA administrators discuss deficiencies they commonly see in the CMC portion of New Drug Applications and Abbreviated New Drug Applications. Richard Lostritto, Director of Division-III in FDA's Office of New Drug Quality Assessment is joined on this panel by Aloka Srinivasan, and Robert Iser, both Team Leaders in FDA's Office of Generic Drug, to offer an unprecedented glimpse into FDA's considerations of new drug applications. The panelists will offer brief presentations and then open up the floor to questions from the audience.
|Deficiencies in New Drug Applications|
Room: 1E14 ~ 9:00 am - 10:00 am (Wednesday, April 21, 2010)
Speaker: Richard Lostritto - Director of Division-III, Office of New Drug Quality Assessment (ONDQA), FDA