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Vaccines

Email - PREA Request, April 6, 2009 - Menveo

From:                     Valenti, Elizabeth
Sent:                      Monday, April 06, 2009 4:25 PM
To:                         'christopher.webster@novartis.com'
Cc:                         Valenti, Elizabeth; Fiore, Cara
Subject:                 PREA Request

Importance:            High
Chris,

According to PREA, pediatric studies may only be deferred if an applicant submits a certification of grounds for deferring the studies.  Please submit a certification of grounds for deferring pediatric studies, a description of the planned or ongoing studies, evidence that the studies are being conducted or will be conducted with due diligence and at the earliest possible time, and a timeline for the completion of the studies.  The description of the planned or ongoing studies should include study design, population, vaccine comparator, subject numbers, primary objective, primary endpoint, secondary objective, secondary endpoint, and timeline for each study planned or underway.

This should be submitted as the Pediatric Plan to the Pediatric Administrative Section of the BLA.  Please submit this to the BLA by 10:00 AM Wednesday, April 8, 2009.

Thank you, Betsy