“OFF-LABEL” USE

2/1/02


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Table of Contents

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“OFF-LABEL” USE

Labeling Requirement[44FR, 6/26/79]

1994 Pediatric Rule

Major Initiatives

FDAMA - Sec. 111

Response to Pediatric Exclusivity As of 1/01/02

Types of Studies Requested As of 1/1/02 (under FDAMA)

Health Impact of New Labels (1/01/02)

Significant label changes

Major Initiatives

1998 Final Rule

Deferred Submission of Studies

Pediatric Studies are Waived if

Important Points of the Rule

1998 Final Rule 4/99-6/01+

Final Rule vs. FDAMA

Best Pharmaceuticals for Children Act Signed into Law 1/04/02

Off Patent Drugs

Off Patent Drugs (continued)

Labeling

Best Pharmaceuticals for Children Act (BPCA)

Best Pharmaceuticals for Children Act (continued)

BPCA continued Adverse Events

To Find out More

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Author: CDER User