FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
Update on FDAs Pediatric Labeling Regulations and Initiatives on Patient Drug Information
Overview of Presentation
Pediatric Drug InformationWho 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 1994Did It Work?
Pediatric ExclusivityWhat Is It?
Pediatric ExclusivityIs It Working?
Pediatric Exclusivity#11; Is It Really Working?
Pediatric ExclusivityFuture?
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?
Product Labeling
Container/Package Labels forPrescription Drugs
Container Labels forPrescription Drugs
Prescription Drug LabelingGoals
Prescription Drug LabelingContent and Format
Adequate Directions for Use
Patient Package Insert
Patient Package InsertRecent Examples
Medication Guides for Prescription Drugs
Medication Guides
Medication Guides#11; What are Triggers?
Medication GuideContent and Format
Tell Me More
Download presentation source
Last update: July 11, 2005
CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page
FDA/Center for Drug Evaluation and Research