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Richard Lostritto

Director of Division-III, Office of New Drug Quality Assessment (ONDQA)

FDA

Speaker Bio

Richard (Rik) Lostritto, Ph.D., joined the FDA in 1995 and currently serves as Director of Division-III in the Office of New Drug Quality Assessment (ONDQA). His areas of CMC (chemistry, manufacturing, and controls) responsibility include drug products indicated for oncology, hematology, and medical imaging as well as a separate branch specializing in manufacturing science. Within the FDA, Dr. Lostritto had previously served as CMC Team Leader collocated in the Divisions of Oncology Drug Products and Pulmonary and Allergy Drug Products.

Before joining the Agency, Dr. Lostritto worked at Boehringer Ingelheim Pharmaceuticals developing medical aerosol formulations after serving as Assistant/Associate Professor of Pharmacy at The University of Connecticut (1983-1992). He received his M.S. and Ph.D. Degrees in Pharmaceutical Chemistry and Pharmaceutics from the University of Michigan and his B.S. Degree in Pharmacy from The University of Connecticut.

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Wednesday, April 21, 2010

Signature Series

Deficiencies in New Drug Applications
Room: 1E14 ~ 9:00 am - 10:00 am (Wednesday, April 21, 2010)

Presented by Pharmaceutical Technology:

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.

Speaker:

Robert Iser, MS - Office of Generic Drugs, CDER, FDA

Richard Lostritto - Director of Division-III, Office of New Drug Quality Assessment (ONDQA), FDA

Aloka Srinivasan - Office of Generic Drugs, CDER, FDA

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