Speaker: Jennifer L. Kirk, Center for Biologics Evaluation and Research, Food and Drug Administration
Title: Statisticians at the U.S. Food and Drug Administration
Abstract: Since the passage of the Pure Food and Drug Act in 1906, the U.S. Food and Drug Administration (FDA) has worked to protect the American people by regulating a wide variety of products, including food and cosmetics, medicines and medical devices, animal foods and drugs, as well as tobacco products. Statisticians play an integral role in the FDA’s work, providing technical expertise to the scientific experts at the FDA. With the passage of the 21st Century Cures Act and the PDUFA VI Act, FDA is exploring the use of real-world data and complex and innovative trial designs. These two programs provide exciting opportunities for statisticians to work on new statistical problems in the regulatory context.
Seminar Date/Time: Thursday May 21st, 4:10pm
This seminar will be delivered remotely via Zoom. To access the Zoom meeting for this seminar, please contact the instructor Shizhe Chen (firstname.lastname@example.org) or Pete Scully (email@example.com) for the meeting ID and password, stating your affiliation.