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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, December 5, 2011 - 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: 05-Dec-2011 03:43 PM        Initiated by FDA? No
Telephone Number: jody.a.gould@gsk.com
Communication Categorie(s):
1. Other -

Author: KIRK PRUTZMAN
Telecon Summary:
GSK would like Amendment 15 reviewed (PI changes for PFS)
FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK
Non-FDA Participants: JODY GOULD
Trans-BLA Group: No

Related STNs: None
Related PMCs: None
Telecon Body:
Dear Kirk,

This email is in follow up to a phone discussion I had with Joe this afternoon.  I just wanted to draw to your attention the amendment we submitted to the BLA on September 19, 2011 (Sequence 0015).  This amendment includes a m1.11.1 document that describes proposed instructions for the Dosage and Administration section of the PI when diluent –b(4)---------- is used.  As CBER is not planning to assess the information submitted on November 30 regarding diluent in vials, the September 19 amendment should be reviewed now in support of the current  --b(4)------ presentation.

In our eCTD viewer at GSK, this m1.11.1 document can be seen in “Current view” or under the specific amendment (sequence 0015).  I assume it will be the same for CBER reviewers. 

Please feel free to contact me with any questions.

Thanks,

Jody
Jody Ann Gould, PhD
Senior Director
US Regulatory Affairs
jody.a.gould@gsk.com
610-787-3765 (phone)
610-787-7063 (fax)


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