Submission ID: Office:
BLA 125300 OVRR
Title: Meningococcal (Neisseria meningitidis) Tetravalent Oligosccharide Serogroups A, C, Y, W-135 Conjugate (diphtheria toxin CRM197; Corynebacterium diphtheriae) Vaccine
Sponsor: Novartis Vaccines and Diagnostics Inc
Telecon Date/Time: 07-Jan-2010 2:00 PM Initiated by FDA?: yes
Telephone Number: call in
Author: CARA FIORE
Purpose: ADVICE on the proposed pharmacovigilance plan
- Email 07Jan10 - PVP comments conveyed.
- Amendments 017
These two items were conveyed for discussion to sponsor 07Jan10 by email:
- CBER requests that the chart reviewer who confirms the onset date of an Event of Interest (EOI) be masked from the date of receipt of Menveo. CBER acknowledges that the chart reviewer will not be masked from the fact that the research subject received Menveo at some point
- CBER would also like to ask about the estimated turnaround time for the pregnancy registry protocol.
This could be done, but this is just a chart review they would have to redact the information and an intermediary would have to do this. It would slow the review process quite a bit. The EOI on this is limited as well. The effort and complication on this may not be worth the additional work.
Sometimes the chart review may not yield the answer. And then they would have to analyze the data and look at the worst and best case scenario to determine the EOI. It may slow the process down by as much as 6 months.
CBER acknowledges this. CBER asks when is the pregnancy registry protocol coming in?
Novartis claims they sent it Dec 24th. Serial 18 may have it as well. For the P34 safety protocol - when does novartis have to have that in by? Before the Action date?
CBER: As long as this one single issue is addressed, then the protocol is okay as is. OBE preference would be to see the final protocol before the action due date, since Novartis had previously planned to send it the end of Jan.
Novartis: do you have any comments on the risk management plan for the BLA?
CBER: (Only W. Vann, C. Fiore and E. Valenti were on the phone at this time). CBER will get back to you.
Novartis: The -----b(4)_---------------------------------------------------------------------.
- Novartis did not send in the pregnancy registry. They were contacted by C . Fiore and promptly sent it in.
- OBE has already provided all the risk management comments that OBE has presently.