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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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PeRC Decision - October 2, 2009

From:                     Greeley, George 
Sent:                      Friday, October 02, 2009 6:37 PM
To:                          Jain, Nisha
Cc:                          Stowe, Ginneh D.
Subject:                BLA 125329 Gammaplex
Importance:        High

Hi Nisha,

The Gammaplex (Immune Globulin Intravenous (Human)) partial waiver, deferral and plan was reviewed by the PeRC PREA Subcommittee on August 26, 2009. 

The Division recommended a partial wavier from 0-2 years because there are too few children with disease/condition to study and a deferral from <2-16 years because the product is ready for approval in adults. 

Thank you.

George Greeley
Regulatory Health Project Manager
Pediatric and Maternal Health Staff
Office of New Drugs
10903 New Hampshire Ave.
Bldg #22, Room 6467
Silver Spring, MD 20993-0002