Pediatric Drug Development Overview of FDA Initiatives

5/18/01


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Table of Contents

Pediatric Drug Development Overview of FDA Initiatives

Chronology of initiatives

Pediatric labeling - 1979

Problems with 1979 rule

The 1994 rule

1994 rule

Impact of the 94 rule

1998 rule

Timing of pediatric studies

What types of studies?

Impact of 1998 rule

FDAMA - Exclusivity Provisions

FDAMA vs Rule

Impact of FDAMA

ICH E-11

Subpart D regulations

Citations I

Citations II

Author: CBER