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Exclusivity Statistics

7/2/99

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Table of Contents

Exclusivity Statistics

An Act 105th Congress

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TOTAL PPSR Actions

Exclusivity Summary

Average Time to Issuance of Written Requests

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Written Request Types of of Studies As of May 31, 1999

Efficacy Trials (as of 5/31/99) Probable: Different Disease Expression or Response to Therapy

Safety Studies

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Percentage of AERs cases by age 1997-1998

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“Other” Studies

Ages Included in Written Requests

AGES: OTHER

Number of Pediatric Patients As of May 31, 1999

Approved Drug Products to which FDA has issued a Written Request for Pediatric Studies

Approved Drug Products to which FDA has issued a Written Request for Pediatric Studies

Approved Drug Products to which FDA has issued a Written Request for Pediatric Studies

Approved Drug Products to which FDA has issued a Written Request for Pediatric Studies

Impact Enormous

Issues

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Committees and Working Groups

To Find out More

 Author: Dianne Murphy, M.D.

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