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Food and Drug Administration Modernization Act of 1997

FDA Plan For Statutory Compliance
November 1998

Table of Contents

Executive Summary

Part One: Strategic Framework

• Purpose
• Scope
• The Mandated Strategic Framework
• FDA's Strategic Management Approach
  • Mission Development
  • Emerging FDA Challenges
  • Analysis of the Gap between What is Expected of FDA and Its Actual Performance
  • Stakeholder Consultation
  • Identification of Agency-wide Objectives and Strategic Directions
    

Part Two: FDAMA Plan for FY 1999 Objective A: Information about Review Processes

• Objective B: Information about New Products
• Objective C: Implementing Inspection and Postmarket Monitoring Provisions
  • Subobjective C1: Assuring Product Safety
  • Subobjective C2: Adverse Event Reporting
• Objective D: Science and Research
• Objectives E and F: Eliminating Backlogs

Appendices

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