CDER s Office of Drug Safety Electronic Tools for

CDER's Office of Drug Safety: Electronic Tools for Risk Assessment and Evaluation March 31, 2006 FDA Science Board 1

March 31, 2006 FDA Science Board 2

Background: Premarket March 31, 2006 FDA Science Board 3

Background: Premarket March 31, 2006 FDA Science Board 4

Background: Premarket March 31, 2006 FDA Science Board 5

March 31, 2006 FDA Science Board 6

March 31, 2006 FDA Science Board 7

The Adverse Event Reporting System - AERS March 31, 2006 FDA Science Board 8

Adverse Event Reports by Year March 31, 2006 FDA Science Board 9

Data Mining March 31, 2006 FDA Science Board 10

Data Mining in AERS March 31, 2006 FDA Science Board 11

Web. VDME March 31, 2006 FDA Science Board 12

Supplements to AERS March 31, 2006 FDA Science Board 13

March 31, 2006 FDA Science Board 14

March 31, 2006 FDA Science Board 15

March 31, 2006 FDA Science Board 16

March 31, 2006 FDA Science Board 17

March 31, 2006 FDA Science Board 18

March 31, 2006 FDA Science Board 19

March 31, 2006 FDA Science Board 20

March 31, 2006 FDA Science Board 21

March 31, 2006 FDA Science Board 22

Epidemiology Contracts March 31, 2006 FDA Science Board 23

Epidemiologic Databases March 31, 2006 FDA Science Board 24

GPRD March 31, 2006 FDA Science Board 25

GPRD March 31, 2006 FDA Science Board 26

All Data Sources Are Valuable March 31, 2006 FDA Science Board 27

Conclusions March 31, 2006 FDA Science Board 28