Statistics at the FDA: Some Observations on Statistical Reviewing at the FDA

George Mason University
CSI/Statistics Colloquium Series
Seminar Announcement

Statistics at the FDA: Some Observations on Statistical Reviewing at the FDA

Peter A. Lachenbruch, Chief

Biostatistics Branch
Center for Biologics Evaluation and Research
Food and Drug Administration

ABSTRACT The Center for Biologics Evaluation and Research reviews applications for new biological products such as vaccines, blood products, and biological therapeutics. Suggestions for conducting effective reviews of these products will be mentioned. Websites for finding guidance documents are indicated. Statistical knowledge, computing skills, communication skills that statistical reviewers need will be discussed.

Friday, March 20, 1998
Science-Technology II, Room 320
Seminar at 10:45 a.m.
Refreshments at 10:30 a.m.