FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
Drug Safety and Risk Management Advisory
May 18 & 19, 2005
Today, an overview of both passive and active
surveillance methods currently used by FDA to detect safety signals has been
DAY 1 WEDNESDAY MAY 18, 2005
Please comment on the following topics and
1. The Adverse Event Reporting System (AERS)
- What types of safety problems
are most effectively addressed by using a “passive” surveillance system
such as AERS that depends on voluntary reporting?
- Are there safety problems
where use of this system is less effective?
- If so, please specify the type or nature
of these safety issues where passive surveillance is ineffective.
- How can the FDA passive
surveillance system be improved?
- How can active surveillance
systems be used to augment the currently available FDA systems for safety
signal detection and risk characterization?
- What types of drug products
or safety problems are best suited to active surveillance methods?
- How might active surveillance
systems for drug safety problems be used most efficiently, that is, with greater
specificity and sensitivity?
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?
a. In light of the surveillance methods
described today and the answers to the above
what are the priority data gaps and how might they be filled?