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
Importance:    High
 

Hi Lori,

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.

Thank you.

George Greeley
Regulatory Health Project Manager
Pediatric and Maternal Health Staff
FDA/CDER/OND
10903 New Hampshire Avenue
Bldg. 22, Room 6467
Silver Spring, MD 20993-0002
Phone: 301.796.4025
Email: george.greeley@fda.hhs.gov
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