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
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