CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
Drug Safety and Risk Management Advisory
Committee (DSaRM)
Holiday Inn
May 18 & 19, 2005
QUESTIONS
Today, an overview of both passive and active
surveillance methods currently used by FDA to detect safety signals has been
presented.
DAY 1 WEDNESDAY MAY 18, 2005
Please comment on the following topics and
questions:
1. The Adverse Event Reporting System (AERS)
2. Active
Surveillance
3. Drug Utilization
a. Based upon the presentations today,
what are the priority areas for FDA to expand or
improve its use of drug use data?
4. Surveillance
Gaps
a. In light of the surveillance methods
described today and the answers to the above
questions,
what are the priority data gaps and how might they be filled?