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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