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Vaccines

Record of Telephone Conversation, July 15, 2011 - MenHibrix

 

 
RECORD OF TELEPHONE CONVERSATION
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: 15-Jul-2011 11:45 AM        Initiated by FDA? Yes
Telephone Number: jody.a.gould@gsk.com, norris.h.pyle@gsk.com
Communication Categorie(s):
1. Advice
 
Author: KIRK PRUTZMAN
Telecon Summary:
CBER concurrance with quarantined lots and diluent inspection protocol
FDA Participants: KIRK PRUTZMAN, DAVID STATEN, JOSEPH TEMENAK
Non-FDA Participants: JODY GOULD, NORRIS PYLE
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
Dear Dr. Gould,
 
CBER has discussed your proposed Manual Visual Inspection protocol and your proposed shipping of quarantined lots of MenHibrix bulk conjugate. 
 
Regarding the issues of the Manuel Visual Inspection for the diluent for Menhibix, CBER concurs with your proposed inspection plan in your email dated July 14, 2011. 
 
Regarding your questions about sending bulk conjugate lots under quarantine proposed in an email dated July 11, 2011, CBER accepts these lots. You may ship them as soon as they are ready.  
 
Regards,
 
Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville, MD 20857
Phone: (301) 796-2640