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
FDAMA Process
PPT Slide
FDAMA Activity As of March 1, 2000
Pediatric Exclusivity Statistics by Division As of March 1, 2000
Pediatric Exclusivity Statistics by Division As of March 1, 2000
PPT Slide
PPT Slide
PPT Slide
PPT Slide
Types of Studies Requested As of March 1, 2000
Estimated Number of Children As of March 1, 2000
Exclusivity Summary
PPT Slide
Exclusivity Granted sNDA/NDA From 7-1-98 to 1-6-00 Approved Products
Pediatric Exclusivity Changes in Labeling For Children (as of March 1, 2000)
Exclusivity Granted sNDA/NDA From 7-1-98 to 1-6-00 Approved Products
Pediatric Exclusivity Changes in Labeling For Children (as of March 1, 2000)
Exclusivity Granted sNDA/NDA From 7-1-98 to 1-6-00 Approved Products
Pediatric Exclusivity Changes in Labeling For Children (as of March 1, 2000)
Exclusivity Granted sNDA/NDA From 7-1-98 to 1-6-00 Approved Products
Pediatric Exclusivity Changes in Labeling For Children (as of March 1, 2000)
Exclusivity Granted sNDA/NDA From 7-1-98 to 1-6-00 Approved 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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