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Exclusivity Statistics
An Act105th Congress
PPT Slide
TOTAL PPSR Actions
Exclusivity Summary
Average Time to Issuance of Written Requests
Written Request Types of of StudiesAs of May 31, 1999
Efficacy Trials (as of 5/31/99)Probable: Different Disease Expression or Response to Therapy
Safety Studies
Percentage of AERs cases by age 1997-1998
Other Studies
Ages Included in Written Requests
AGES: OTHER
Number of Pediatric PatientsAs of May 31, 1999
Approved Drug Products to which FDA has issued a Written Request for Pediatric Studies
ImpactEnormous
Issues
Committees and Working Groups
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