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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
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.
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