Table of Contents
Pre-marketing Drug Risk Assessment,
CDER Executive Staff Briefing,
RAPS 2002 Annual Conference
Outline
Where does pre-market drug risk assessment start?
Safety: Requirement for Approval
[Food, Drug, and Cosmetic Act (Sec. 505)]
Safety assessment during drug development
Goals of the NDA safety review
Approach to the review of
safety data in an NDA
Different approaches:
safety v. efficacy data
Characterizing the extent of drug exposure in the safety database
Components of an
NDA safety database review
Sources of NDA safety data
What is an adverse event?
Serious adverse event
Risk factors to explore
Causality Assessment
Assessing drug-relatedness of adverse events- using a populational approach
Evaluation of rare events
Evaluation of common events
What types of comparative data are available?
Other useful information in
considering causality
Evaluation of supplementary data
Guidance to Industry on
Drug Risk Assessment
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Author:
Judy Racoosin, MD, MPH
Safety Team Leader
Division of Neuropharmacological Drug Products,
Office of New Drugs, CDER, FDA
Download presentation source
[PowerPoint format]
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