Table of Contents
SAFETY REPORTING #11; FDA’s Perspective
Agenda
Agenda
Purpose of the Program
Geographic Profile of FDA Applicants
Brief Overview of Postmarketing Reporting Regulations
Significance of Deviations
Common Causes for Failure to Report ADRs
Training of Staff
Contractual agreements
Patient Assistance Programs
Electronic Transmission Issues
Even with Electronic Advances...
Problems with Process Flow
Problems Found in Standard Operating Procedures
Elements of Good Standard Operating Procedures
Significance of Deviations
Incomplete or Inaccurate Reporting
Inspectional Scope
Source Documents
Source of Adverse Events
Lateness
Percent of FDA-483s Containing the Listed ADE Deficiencies 1997-2000
Outcomes of Inspections
Industry Corrective Actions
Industry Corrective Actions
Industry Corrective Actions
Industry Challenges
Cont. Industry Challenges
Cont. Industry Challenges
Recordkeeping Requirements
ADE Inspections 5-Year Summary
Lessons Learned Integrated Systems
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