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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Review Committee Meeting Summary, July 7, 2009 - Spherusol

Memo to File: BLA 125354.0  

 
Review Committee Meeting Summary
July 7, 2009 2:00 PM
 
Attendees: Bridgewater, Jennifer, Campbell, Karen M., Cato, Dennis, Daugherty, Jon, Hawkins, Anthony, Jingyee, Kou, Miller, Catherine, Morris, Sheldon, Mosquera, Alexis, Schwartz, Ann, Trout, Deborah, Wieland, Holly.
 
The purpose of the meeting was to determine whether the application had adequate content, presentation, and organization of information to permit a substantive and meaningful review. The review team acknowledged that the product has a complex regulatory history ---------------(b)(4)---------------. The review team agreed that while there were deficiencies in the application, this application, BLA 125354.0, was acceptable for filing, and any deficiencies identified would be addressed during the review.
 
Additional discussion regarding deadlines and action items are as follows:
Reviewers: Hawkins, Anthony, Miller, Catherine, Schwartz, Ann, and Trout, Deborah, have entered their filing memos into the database.
 
Other action deadlines include:
 
Other reviewers will enter their filing reviews by July 26th.
 
A “Filing Notification” letter will be issued by July 26, 2009. Reviewers will submit comments to this draft letter by July 17th
 
A “Deficiencies Identified” letter will be issued by August 7, 2009. Reviewers will submit comments to this draft letter by July 30th.
 
Submitted by:
Holly Wieland, RN, MPH
Office of Vaccine Research and Review
Division of Vaccines and Related Product Applications