Vaccines, Blood & Biologics
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BLA 125197 Provenge - Provenge, March 7, 2010
From: Greeley, George
Sent: Sunday, March 07, 2010 1:45 PM
To: Tull, Lori
Cc: Stowe, Ginneh D.
Subject: BLA 125197 Provenge
The Provenge (sipuleucel-T) full waiver was reviewed by the PeRC PREA Subcommittee on January 27, 2010.
The Division recommended a full waiver because disease/condition does not exist in children.
The PeRC agreed with the Division to grant a full waiver for this product.
Regulatory Health Project Manager
Pediatric and Maternal Health Staff
10903 New Hampshire Avenue
Bldg. 22, Room 6467
Silver Spring, MD 20993-0002
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