Record of Telephone Conversation - July 30, 2009

Submission Type: Original Application   Submission ID:  125347/0    Office: OVRR  

Product:
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Applicant:
GlaxoSmithKline Biologicals

Telecon Date/Time:  30-JUL-2009 03:00 PM     Initiated by FDA?  Yes
Telephone Number:    

Communication Category(s):
Other - Postmarketing Commitments

Author:  JASON HUMBERT

Telecon Summary: Dialogue about revisions to the list of PMCs

FDA Participants:   Jason Humbert

Non-FDA Participants:    Elisa Harkins, GSK

Telecon Body: GSK was sent the following e-mail:

Hi Elisa,

Per our discussion, please add a date (we propose -b(4)- months) to PMCs #1 and #3 when the protocol/plan will be submitted.

1. GSK commits to provide a plan/protocol to perform on-going –b(4)-- stability studies on --b(4)-- of Purified Hib-TT bulk conjugate per year. The bulk -b(4)- chosen for stability will not be the same -b(4)- which is used to manufacture the Hiberix final container placed on stability.

3. GSK commits to provide a plan/protocol to address the 24 hour hold time after reconstitution during on-going --b(4)--- stability

Thanks,
Jason

GSK later provided the following e-mail in response:

Hi Jason,

Please find revised PMCs attached with the date of December 31, 2009 cited for the below requests, per our conversation. Please let me know as soon as possible if this is acceptable so that I may place it in the formal submission intended to be filed tomorrow.

Thank you!
Elisa

 

GSK will provide the following Post-Marketing Commitments (PMCs) to BLA 125347 for Hiberix® [Haemophilus B Conjugate Vaccine (Tetanus Toxoid Conjugate)] within the time frames listed. All PMC studies filed to the Hiberix BLA will be identified as PMC submissions.

Regarding Stability

1. GSK commits to provide a plan/protocol to perform on-going ---b(4)--- stability studies on --b(4)-- of Purified Hib-TT bulk conjugate per year by December 31, 2009. The bulk -b(4)- chosen for stability will not be the same -b(4)- which is used to manufacture the Hiberix final container placed on stability.

2. GSK commits to follow -b(4)- US commercial lots in stability according to the stability plan provided in Amendment 17 (Table 17). The lots of Hiberix placed on stability will be manufactured from different formulation batches. The study will be submitted to the license application file for review upon completion. After the first year of approval, GSK commits to have -----b(4)-------------- per year followed in stability. The stability data will be available for review during inspection.

3. GSK commits to provide a plan/protocol to address the 24 hour hold time after reconstitution during on-going ---b(4)--- stability by December 31, 2009.

Regarding Hold Time Validation

4. ------------------------b(4)-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

5. --------------------------------------b(4)--------------------------------------------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------.

6. ------------------------------------------------b(4)----------------------------------------------------------------- --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.

3 Pages determined to be not releasable: b(4)