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Vaccines

Telecon - Drug Substance Testing, December14, 2009 - Menveo

System Info - 114108  SHONE, DEANNA   16-Dec-2009 16:50:52  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125300/0    Office: OVRR  

Product:
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Applicant:                                                                       
Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  14-DEC-2009 03:19 PM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  CARA FIORE

Telecon Summary:
Drug substance testing

FDA Participants:  
Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
From:                     Fiore, Cara 
Sent:                      Monday, December 14, 2009 3:19 PM
To:                          'christopher.webster@novartis.com'
Cc:                          Valenti, Elizabeth; Fiore, Cara
Subject:                Drug substance testing

Dear Chris,
Here are the requests regarding the testing we spoke of this morning:

1. Formaldehyde - Please add back the testing for -----b(4)---------------------------------------------------------------------------
2. ----b(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Thanks,
Cara

Cara Fiore, Ph D
Division of Vaccines and Related Products Applications
Office of Vaccines Research & Review
Center for Biologics Evaluation & Research
U.S. Food & Drug Administration
WOC1 RM300N HFM-481
1401 Rockville Pike
Rockville, MD  20852