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FDA Responds to the Challenge:The Pediatric Subcommittee
Pediatric Subcommittee: (Pedicomm)
Pedicomm
Final Rule - 1994
Final Rule - 1994 (cont.)
The Pediatric Plan
Pedicomm/Membership
Pedicomm/Aiders and Abettors
Pedicomm Gets Started
Pedicomm Communication
Working Groups
Working Groups (cont.)
Important Event
President Clinton announces the Proposed Rule to require studies in pediatrics
The Proposed Rule
The Proposed Rule (cont.)
The Proposed RuleScope
The Proposed RuleRequired studies
The Proposed RuleDeferred submission
The Proposed RuleDeferred submissions (cont.)
The Proposed RuleWaivers
The Proposed RuleWaivers (cont.)
The Proposed RuleMarketed products
The Proposed RulePublic Meeting
The Proposed RuleComments
Pedicomm in Action Pediatric Rapid Response Team
Pediatric FormulationsWorking Group
Clinical Trials Guidance
Modernization Act
Modernization Act (cont.)
The List
The ListProcess
The ListProcess (cont.)
The List Process (cont.)
Timeline for the List
Pediatric Home Page
Last update: July 8, 2005
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