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Exclusivity - Pediatrics - 505(b)(2)s
What is exclusivity?
How many types of exclusivity are there?
What is pediatric exclusivity?
Effect of Pediatric Exclusivity
Applications to Which Pediatric Exclusivity Applies
Moieties in Multiple Products
How does a sponsor qualify for pediatric exclusivity?
Written Requests
Can you earn more than one 6-month period of pediatric exclusivity?
Sunset
Report to Congress
Actions as of 12/1/99
Pediatric Exclusivity Determinations as of 12/1/99
Pediatric Exclusivity Summary
Resources on Pediatric Exclusivity
How do 505(b)(2) applications fit into the world of exclusivity?
What is a 505(b)(2) application?
What information can an applicant rely on?
Examples of 505(b)(2) applications
Resources on 505(b)(2) applications
Exclusivity & Patent Listings
Where can I get more information?
Leanne Cusumano Regulatory Counsel Center for Drug Evaluation and Research
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