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
Trade secret and/or confidential commercial information contained in this message (including any attachments) is exempt from public disclosure to the full extent provided under law. If you are not the intended recipient of this message, or if you are not responsible for delivering it to the intended recipient(s), do not use, disclose, reproduce, or distribute this message (including any attachments). If you have received this message in error, please erase all copies (including any attachments) and notify me immediately. Thank you.