ADVERSE EVENT REPORTING ------------------------------------------------------------------------------------------------------- Reporting Regulations and Guidances Annual Adverse Event Experience Report 1996 "Medical Dictionary for Regulatory Affairs Activites (MedDRA)" MedDRA Subscription Information MedDRA Maintenance and Support Services Organisation (MSSO) Submit the Voluntary MedWatch Form (3500) Online FDA Medical Bulletin Archives How to Report Adverse Reactions Enforcement of the Postmarketing ADE Reporting Regulations

MEDWATCH ------------------------------------------------------------------------------------------------------- MedWatch-What's New Download Medwatch PDF Instructions How to Report Adverse Reactions & Other Problems Reporting by Consumers Reporting by Health Professionals What is a Serious Adverse Event? What is a Product Problem? Medical Products Regulated by FDA Reporting by Drug/Biologic Manufacturers, Distributors, and Packers Reporting Problems with Medical Devices Dear Health Professional and Safety Notifications Labeling Changes Related to Drug Safety. Safety Related Drug Labeling Change Summaries 1998 Important Product Safety Information MedWatch Partners

AERS (ADVERSE EVENT REPORTING SYSTEM) ------------------------------------------------------------------------------------------------------- AERS Reporting System How to Report Adverse Reactions and Other Problems AERS Features AERS Electronic Submissions

COMPLIANCE ------------------------------------------------------------------------------------------------------- FDA Enforcement Report FDA Compliance Program Guidance FDA Recall Policies Product Recalls, Alerts, and Warnings Archive Warning Letters and Notice of Violation Letters Enforcement of Postmarketing ADE Regulations Warning Letters by Issuing Office Warning Letters Indexed by Date Warning Letters by Company Most Recent Warning Letters

LABELING ------------------------------------------------------------------------------------------------------- Labeling Changes Related to Drug Safety 2002 Labeling Changes Related to Drug Safety 1999 Labeling Changes Related to Drug Safety 1998

ICH ------------------------------------------------------------------------------------------------------- ICH Page

VAERS (Vaccine Adverse Event Reporting System) ------------------------------------------------------------------------------------------------------- VAERS (Vaccine Adverse Event Reporting System)

ADVERSE EVENT REGULATIONS RELATED TO DRUG SAFETY ------------------------------------------------------------------------------------------------------- 21 CFR 310.305 - Records & reports of adverse drug experiences on marketed drugs (no approved NDA) 21 CFR 312.32 -- IND Safety Reports 21 CFR 314.80 -- Postmarketing reporting of adverse drug experiences. 21 CFR 600.80 - Postmarketing reporting of adverse experiences.