
Record of Email Communication, February 2, 2010 AM - MenHibrix

 

Submission Type: BLA       Submission ID: 125363/0      Office: OVRR Product:

Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

 

Applicant:

GlaxoSmithKline Biologicals

 

Telecon Date/Time: 02-Feb-2010 12:00 AM           Initiated by FDA? Yes

Telephone Number: Communication Categorie(s):

1. Other - Request for column for testing

 

Author: CAMPBELL, KAREN Telecon Summary:

Request for qualified --------------------(b)(4)------------------------------------------------------------- for MenC-TT and MenY-TT conjugates in the final container vaccine

 

FDA Participants: Karen Campbell

 

Non-FDA Participants: Norris Pyle, GSK

 

Telecon Body: The following was provided to GSK via e-mail:

 

Dear Norris,

 

 

In the testing lab we are interested in receiving a qualified --------(b)(4)---------- supplied by                       ---(b)(4)----- used in performing the test for ------------(b)(4)------------------------------------ for MenC- TT and MenY-TT conjugates in the final container vaccine.

 

Please contact me if you have any questions. The column can be sent to:

Al Del Grosso

 

Center for Biologics Evaluation and Research

Nicholson Lane Research Center, Lab B209

5516 Nicholson Lane

Kensington, MD 20895

Telephone 301 435 4988

 

 

Karen Campbell