Table of Contents
Where have we been and where are we heading? How far have we come?
PPT Slide
PPT Slide
Pediatric Labeling Benchmarks
Pediatric Rule of 1994
Pediatric Rule of 1994
1994 RESPONSE
2 Major Approaches
FDAMA Incentive
FDAMAProcess
PPT Slide
FDAMA Activity As of March 1, 2000
Pediatric Exclusivity Statistics by DivisionAs of March 1, 2000
Pediatric Exclusivity Statistics by DivisionAs of March 1, 2000
PPT Slide
PPT Slide
PPT Slide
PPT Slide
Types of Studies Requested As of March 1, 2000
Estimated Number of ChildrenAs of March 1, 2000
Exclusivity Summary
PPT Slide
Exclusivity GrantedsNDA/NDAFrom 7-1-98 to 1-6-00Approved Products
Pediatric Exclusivity Changes in Labeling For Children (as of March 1, 2000)
Exclusivity GrantedsNDA/NDAFrom 7-1-98 to 1-6-00Approved Products
Pediatric Exclusivity Changes in Labeling For Children (as of March 1, 2000)
Exclusivity GrantedsNDA/NDAFrom 7-1-98 to 1-6-00Approved Products
Pediatric Exclusivity Changes in Labeling For Children (as of March 1, 2000)
Exclusivity GrantedsNDA/NDAFrom 7-1-98 to 1-6-00Approved Products
Pediatric Exclusivity Changes in Labeling For Children (as of March 1, 2000)
Exclusivity GrantedsNDA/NDAFrom 7-1-98 to 1-6-00Approved Products
Pediatric Exclusivity Changes in Labeling For Children (as of March 1, 2000)
2 Major Approaches
1998 Final Rule
New Drugs
Marketed Drugs
Meaningful Therapeutic Benefit
Substantial Use
Final Rule Effective: April 1, 1999
Key Elements
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Author: Rosemary Roberts
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