Risk-Management Options

3/19/01


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Table of Contents

Risk-Management Options

Risk-Management Options for Marketed Drugs

Labeling Components

Patient Package Inserts (PPI)

Medication Guides for Prescription Drugs

Lotronex Labeling: Anticipated Principal Changes

Warnings

Warnings

Boxed Warnings

Boxed Warnings

Boxed Warnings: How Used?

Boxed Warnings: How Used?

Boxed Warnings: How Used?

Boxed Warning for Lotronex?

Boxed Warning for Lotronex?

Communications and Educational Programs

Communications and Educational Programs

Communications and Educational Programs

Advertising

Packaging and Restricted Distribution

Withdrawal

Conclusion

Discussion Points

Author: Victor Francis Charles Raczkowski