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Update on FDA’s Pediatric Labeling Regulations and Initiatives on Patient Drug Information
Overview of Presentation
Pediatric Drug Information Who Needs It?
Principal Tools Available to FDA
Other Communications by FDA
Principal Tools Available to Companies
Pediatrics: Why Now?
Pediatric Laws and Regulations #11; Core Provisions
Labeling Changes 1979
Pediatric Rule of 1994
Pediatric Rule of 1994 Did It Work?
Pediatric Exclusivity What Is It?
Pediatric Exclusivity Is It Working?
Pediatric Exclusivity #11; Is It Really Working?
Pediatric Exclusivity Future?
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?
Product Labeling
Container/Package Labels for Prescription Drugs
Container Labels for Prescription Drugs
Prescription Drug Labeling Goals
Prescription Drug Labeling Content and Format
Adequate Directions for Use
Patient Package Insert
Patient Package Insert Recent Examples
Medication Guides for Prescription Drugs
Medication Guides
Medication Guides #11; What are Triggers?
Medication Guide Content and Format
Tell Me More
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Last update: July 11, 2005
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