Submission Type: BLA Submission BLA: 125363/12 Office: OVRR
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Date: January 17, 2012 Initiated by FDA? Yes
Telephone/Email: firstname.lastname@example.org, Norris.email@example.com
- Information Request
Author: David Staten
Response to GSK information request concerning revised persistence sample hSBA MenC assay
FDA Participants: David Staten
Non-FDA Participants: Jody Gould, Norris Pyle
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
To:"firstname.lastname@example.org"; "Jody Gould";
cc:Temenak, Joseph; Sutkowski, Elizabeth M.; Prutzman, Kirk C;
Subject:MenHibrix miscellaneous items
Date:Tuesday, January 17, 2012 2:05:58 PM
Norris - Concerning the stability data, recall in our November 8th meeting we agreed that the --(b)(4)-- stability data can be submitted within 2 months of submitting the Complete Response. It is unfortunate that the (b)(4) stability data did not meet specifications. Can you tell us what specifically failed. We would also like to see the data.
We do not agree with your ---(b)(4)--- stability plan. The January 30th amendment must contain real-time data. Given the current situation we are assuming that will be ---(b)(4)--- data. Any additional data, i.e., 30 or 36 months must be submitted as a PAS to the license product (post-licensure). Stability data will not be accepted in an annual report.
Your clarification on the Final Container Samples is clear. When do you plan to submit the lot release protocols?
We acknowledge GSK's risk in proceeding with the testing of (b)(4) samples using the revised hSBA MenC assay. It is not clear why you are planning to use the revised assay. Your email didn't contain enough information for us to provide any additional feedback.