Vaccines, Blood & Biologics
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Review Committee Meeting Summary, November 12, 2009 - Menveo
BLA 125300_0
Novartis ACYW-135 Mening Vaccine
November Review Committee Meeting Agenda
Date | Time | Location | US | Password | International Call in - Toll |
|---|---|---|---|---|---|
Thursday |
3:00 – 4:00 EST PM |
Room 300 N, in Building WOC 1 |
---b(4)------------------ | Participant Passcode --b(4)------ Leader pass code --b(4)--- |
---b(4)--------------- |
- 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
- Recent Amendments
- Running list
- optimizing CRM 197 innocula (0.1)
- Extractables and Leachables (0.2)
- Partial DI response (0.3)
- Partial DI response and additional info (0.4)
- Response to IRs. (0.5)
- HPV V59P18 (0.6)
- Pharmacovigilance Response (0.7)
- Correction to LIMS and updated product list (0.8)
- PerC Deferral Information (0.9)
- 483 response (.10)
- Batch records and product samples (.11)
- Stability Data for 24 months and packaging mock ups
- Specifications and validation of specs, manufacturing data
- Pharmacovigilance plan, ---b(4)---------------, updated 483 responses, Comparability Protocol
- Complete Response (Aug 21, 2009)
- Pre-licensure testing – selection of batches (Oct 8, 2009)
- Stability data to 36 months, batch data for pre-licensure testing, PVP
- Team Reports
- 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.
- 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.
- 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)----------------------------------------------
- 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.
- 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.
- Major Due Dates are on Table below
| Milestones | Date |
| Lot release protocol | asap |
| Lot release testing (consist and launch) | 10/20/09 |
| Labeling - start | Oct/Nov |
| Further BIMO/CMC inspection? | |
| Another facility inspection? | |
| Deficiencies Identified | 11/03/09 |
| Midcycle Review | 11/04/09 |
| Prep of product testing plan | 11/04/09 |
| Final Prop name review | 11/19/09 |
| Final Reviews Due | 12/19/09 |
| PMC to FDAAA Safety WG | |
| Action Package routing | 1/13/09 |
| Lot release clearance | 01/18/10 |
| Approval letter draft | 1/19/09 |
| Action Package to Branch Chiefs | 1/20/10 |
| Final Action Due Date | 2/20/10 |
| Action Package Posting | 2/20/09 |
| Monthly Meetings (Team report) | monthly |
| IOD Monthly Update | monthly |
- Next Meeting –
- December 9, 2009
- Questions/Comments/Concerns?
- Please continue to include Cara and Betsy on emails.
- Action Items
- Dr. Bash to draft language, for review by OVRR management, to gain support for only reviewing the BLA at this time.
- Dr. Freedburg to draft an IR asking that the tests be added back to the plan.
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