


PeRC Decision - October 2, 2009 - Gammaplex


 
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
FDA/CDER
10903 New Hampshire Ave.
Bldg #22, Room 6467
Silver Spring, MD 20993-0002
301.796.4025
 

   