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General Departmental Seminar Series

Drug/Biologics Product Development and Statistical Review at the FDA
Boguang Zhen, Ph.D.
Math Biostatistician
Division of Biostatistics, Office of Biostatistics and Epidemiology
Center for Biologics Evaluations and Research
The US Food and Drug Administration

Friday, September 28
12:00 pm
5275 MSC


This talk will begin with an introduction of the FDA's structure and its mission.  The general process for industry-FDA interaction during the drug/biologics product development will be described briefly.
Statistics plays a very important role in the review process for regulatory submissions.  Statistical reviewers in the drug/biologics product development area need to deal with new clinical trial design issues and their corresponding statistical considerations, as well as need to interpret statistical analysis results in such a way that scientists without strong statistical backgrounds and the public can understand.  Reviewers in the Agency often have to make binary decisions (yes or no) within an established timeframe.  Incorporating statistical inferences into the decision making process appropriately can be challenging.   A real world example will be given and discussed in this talk.

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