Table of Contents
Integrating Pediatric Studies into Drug DevelopmentRegulatory Perspectives
Timing of Pediatric StudiesWhat Factors Influence?
Timing of Pediatric StudiesIndication Being Sought
Timing of Pediatric StudiesTypes of Trials Needed
Timing of Pediatric StudiesNature of Disease
Timing of Pediatric StudiesCharacteristics of Drug
Timing of Pediatric StudiesAvailability 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 1994Did It Work?
Pediatric ExclusivityWhat Is It?
Pediatric ExclusivityWhat Triggers It?
Pediatric ExclusivityWho/What Gets It?
Pediatric Exclusivity: How?
Pediatric Exclusivity: How?
Pediatric ExclusivityIs It Working?
Pediatric Exclusivity#11; Is It Really Working?
Pediatric Exclusivity#11; Is It Really Working?
Pediatric ExclusivityLike Death and Taxes?
Pediatric Rule of 1998What It Is Not
Pediatric Rule of 1998What Is It?
Pediatric Rule of 1998When Does It Apply?
Pediatric Rule of 1998What Triggers It?
Pediatric Rule of 1998#11; Meaningful Therapeutic Benefit
Pediatric Rule of 1998What Is Substantial Use?
Pediatric Rule of 1998What Is a Pediatric Assessment?
Pediatric Rule of 1998What Types of Studies Needed?
Pediatric Rule of 1998What Types of Studies Needed?
Pediatric Rule of 1998What Types of Studies Needed?
Pediatric Rule of 1998What Types of Studies Needed?
Pediatric Rule of 1998What Types of Studies Needed?
Pediatric Rule of 1998Waivers
Pediatric Rule of 1998Partial Waivers
Pediatric Rule of 1998Disease-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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