ARCHIVED VIDEO WEBCAST
CDER
Live!
Broadcast Date: May 20, 2005
Co-sponsored by the Drug Information Association
and the Center for Drug Evaluation and Research, FDA
Program
Title:
"CDER's Drug Safety Initiative"
PROGRAM OVERVIEW
CDER’s
drug safety initiative is a comprehensive program to address
the safety of medicines. A number of steps announced over the past few months will
be discussed during this broadcast:
•The Institute of Medicine (IOM) Study of the Drug
Safety System
•The search for a new Director of the Office of Drug
Safety
•The publication of the final Risk Minimization Guidances
•The creation of a Drug Safety Oversight Board The
proposed “Drug Watch” web page
•The availability of Patient Information Sheets and
Health Care Alerts for drugs with emerging safety issues
•Expanded involvement of non-FDA government experts
when the agency is makingdecisions on significant safety
issues
MODERATOR
Deborah Henderson, Director, Office of Executive
Programs
Center for Drug Evaluation and Research, FDA
PANELISTS
Susan K. Cummins, MD, MPH
Executive Director, Drug Safety Oversight Board,
CDER, FDA
Steven K. Galson, MD
Acting Director, CDER, FDA
John K. Jenkins, MD
Director of the Office of New Drugs, CDER, FDA
Paul J. Seligman, MD, MPH
Director, Office of Pharmacoepidemiology and Statistical
Science, CDER, FDA
Douglas C. Throckmorton, MD
Acting Deputy Director, Center for Drug Evaluation
and Research, FDA
With A Taped Interview Featuring:
Janet Woodcock, MD
Acting Deputy Commissioner for Operations, FDA
LEARNING OBJECTIVES: At the conclusion of the broadcast,
participants should be able to:
- Discuss agency initiatives to improve drug safety
- Explain
CDER’s initiatives to improve the timeliness and availability
of drug safety information
