CDER 2007 Update: Improving Public Health Through Human Drugs

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Contents

• Director’s Message
• Introduction
• Drug Review
• New Drug and Biologic Review
• Generic Drug Review
• Over-the-Counter Drug Review
• Pediatric Drug Development
• Maternal Health Team
• Critical Path Initiative
• Scientific Research
• User Fee Program
• Drug Safety and Quality
• Modernizing Drug Safety
• Drug Promotion Review
• Drug Safety Surveillance
• Drug Recalls and Safety-Based Withdrawals
• Compliance Oversight
• Drug Quality System
• Counterterrorism, Emergency Response
• International Activities
• President’s Emergency Plan for AIDS Relief
• Communications
• Ombudsman Activities
• Appendix
• Glossary of Terms
• Internet Resources
• CDER Organizational Structure

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Date created: July 31, 2008

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