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Record of Telephone Conversation, December 5, 2011 - MenHibrix
Submission Type: BLA Submission ID: 125363/0 Office: OVRR
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 05-Dec-2011 03:43 PM Initiated by FDA? No
Telephone Number: firstname.lastname@example.org
1. Other -
Author: KIRK PRUTZMAN
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
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.
Jody Ann Gould, PhD
US Regulatory Affairs
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