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Vaccines, Blood & Biologics

Review Committee Meeting Summary, November 12, 2009 - Menveo

BLA 125300_0
Novartis ACYW-135 Mening Vaccine

November Review Committee Meeting Agenda




Call in


International Call in - Toll


November 12, 2009


3:00 – 4:00  EST PM


Room 300 N, in Building WOC 1



Participant Passcode         --b(4)------

Leader pass code --b(4)---



  1. Attendees

Al-Humadi, Nabil
Bash, Margaret
Campbell, Karen
Fiore, Cara
Freedberg, Daron
Gupta, Rajesh
Krasnicka, Barbara
Lee, Martha
Stewart-Bennett, Daphne
Sutkowski, Elizabeth
Vann, Willie
Valenti, Elizabeth

  1. Recent Amendments
  1. Running list
    1. optimizing CRM 197 innocula (0.1)
    2. Extractables and Leachables  (0.2)
    3. Partial DI response (0.3)
    4. Partial DI response and additional info (0.4)
    5. Response to IRs. (0.5)
    6. HPV  V59P18 (0.6)
    7. Pharmacovigilance Response (0.7)
    8. Correction to LIMS and updated product list (0.8)
    9. PerC Deferral Information (0.9)
    10. 483 response (.10)
    11. Batch records and product samples (.11)
    12. Stability Data for 24 months and packaging mock ups
    13. Specifications and validation of specs, manufacturing data
    14. Pharmacovigilance plan, ---b(4)---------------, updated 483 responses, Comparability Protocol
    15. Complete Response (Aug 21, 2009)
    16. Pre-licensure testing – selection of batches (Oct 8, 2009)
    17. Stability data to 36 months, batch data for pre-licensure testing, PVP
  1. Team Reports
  1. Clinical – the IND continues to dominate the majority of the review time.  Last week the sponsor was told that focus needed to be put on the BLA, not the IND; however, they then submitted more amendments to the IND.  The sponsor wants answers on retesting in the infant P14 study and toddler P21 study .   Dr. Bash agreed to draft language, for review by OVRR management, to gain support for only reviewing the BLA at this time. 
  2. Statistical – the P14 submission for the IND was also reviewed and a new analysis plan was (for an assessment of agreement of the original test and re-test procedures) proposed.  Review of the BLA will continue next week.
  3. CMC – Daron Freedberg – the sponsor wanted --b(4)----------------- however, rational for ---b(4)------------------ was not satisfactory.  The review is in draft form and the ----b(4)------------------------------------.  An IR will be sent to the sponsor asking -----b(4)----------------------------------------------
  4. Lot Release – Problems should be identified and comments should be sent to the sponsor by mid-December.  The final review memo should be completed by January 15, 2010.   
  5. Labeling – APLB review finished.  The first labeling meeting is November 17, 2009.  OBE, APLB, DE, and Repro Tox have sent comments.  Dr. Vann will review the drug description prior to the labeling meeting.
  1. Major Due Dates are on Table below
Lot release protocolasap
Lot release testing  (consist and launch)10/20/09
Labeling - startOct/Nov
Further BIMO/CMC inspection? 
Another facility inspection? 
Deficiencies Identified11/03/09
Midcycle Review11/04/09
Prep of product testing plan11/04/09
Final Prop name review11/19/09
Final Reviews Due12/19/09
PMC to FDAAA Safety WG 
Action Package routing1/13/09
Lot release clearance01/18/10
Approval letter draft1/19/09
Action Package to Branch Chiefs1/20/10
Final Action Due Date2/20/10
Action Package Posting2/20/09
Monthly Meetings (Team report)monthly
IOD Monthly Updatemonthly
  1. Next Meeting –
    1. December 9, 2009
  1. Questions/Comments/Concerns?
    1. Please continue to include Cara and Betsy on emails.
  1. Action Items
    1. Dr. Bash to draft language, for review by OVRR management, to gain support for only reviewing the BLA at this time. 
    2. Dr. Freedburg to draft an IR asking that the tests be added back to the plan.

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