Table of Contents
Integrating Pediatric Studies into Drug Development Regulatory Perspectives
Timing of Pediatric Studies What Factors Influence?
Timing of Pediatric Studies Indication Being Sought
Timing of Pediatric Studies Types of Trials Needed
Timing of Pediatric Studies Nature of Disease
Timing of Pediatric Studies Characteristics of Drug
Timing of Pediatric Studies Availability of Formulation
Pediatrics: Regulatory History
Pediatrics: Why Now?
Pediatric Laws and Regulations #11; Heart of the Matter
Pediatric Laws and Regulations #11; Heart of the Matter
Labeling Changes 1979
Pediatric Rule of 1994: Kids Are Human Too! (Sometimes)
When Is Sometimes?
Pediatric Rule of 1994 Did It Work?
Pediatric Exclusivity What Is It?
Pediatric Exclusivity What Triggers It?
Pediatric Exclusivity Who/What Gets It?
Pediatric Exclusivity: How?
Pediatric Exclusivity: How?
Pediatric Exclusivity Is It Working?
Pediatric Exclusivity #11; Is It Really Working?
Pediatric Exclusivity #11; Is It Really Working?
Pediatric Exclusivity Like Death and Taxes?
Pediatric Rule of 1998 What It Is Not
Pediatric Rule of 1998 What Is It?
Pediatric Rule of 1998 When Does It Apply?
Pediatric Rule of 1998 What Triggers It?
Pediatric Rule of 1998 #11; Meaningful Therapeutic Benefit
Pediatric Rule of 1998 What Is Substantial Use?
Pediatric Rule of 1998 What Is a Pediatric Assessment?
Pediatric Rule of 1998 What Types of Studies Needed?
Pediatric Rule of 1998 What Types of Studies Needed?
Pediatric Rule of 1998 What Types of Studies Needed?
Pediatric Rule of 1998 What Types of Studies Needed?
Pediatric Rule of 1998 What Types of Studies Needed?
Pediatric Rule of 1998 Waivers
Pediatric Rule of 1998 Partial Waivers
Pediatric Rule of 1998 Disease-specific Waivers
Timing of Pediatric Studies
Timing of Pediatric Studies
Pediatric Formulations
1998 Rule vs. FDAMA
1998 Rule vs. FDAMA
1998 Rule vs. FDAMA
1998 Rule vs. FDAMA
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