Table of Contents
Pediatric Initiatives
The Problem
Pediatric Regulations & Legislation
1994 Pediatric Rule
PEDIATRIC EXCLUSIVITY
Effect of Pediatric Exclusivity
Applications to Which Pediatric Exclusivity Applies
Moieties in Multiple Products
Can you earn more than one 6-month period of pediatric exclusivity?
The Statute: Section 505A
Qualifying for Pediatric Exclusivity Under the Statute
List of Approved Drugs (505A(b))
“Priority” Section of the List
Obtaining Pediatric Exclusivity
Written Requests
Relationship to Regulations
Sunset
Sunset
Report to Congress
Actions as of 9/1/99
Pediatric Exclusivity Grants as of 9/1/99
Resources on Pediatric Exclusivity
Key Elements
1998 Final Rule
Applications Covered by Rule
Marketed Drugs
Meaningful Therapeutic Benefit
Substantial Number of Pediatric Patients
What is a Pediatric Assessment?
Deferral Criteria
To Request Deferral
To Request Waiver
Scope of Waiver
Final Rule Implementation Dates
Implementation and Comparison
Rule Compared to Ped. Ex.
Rule Compared to Ped. Ex.
Rule Compared to Ped. Ex.
Implementation of Pediatric Initiatives
Pediatric Rule & the Approval Letter
Pediatric Advisory Subcommittee
Pediatric Subcommittee Meetings
Ultimate Goal
To Find out More |
Author: Leanne Cusumano, Regulatory Counsel, CDER (10/13/99)
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