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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

October Monthly Meeting Summary - Menveo

BLA 125300_0
Novartis ACYW-135 Mening Vaccine
W. Vann, Chair
C. Fiore, Primary Reviewer

October Monthly Meeting Summary (comments in itals)

  1. Introductions

The following people attended either by phone or in person:

Al-Humadi, Nabil
Austin-Hansberry
Bash, Margaret
Blake, Milan
Burns, Drusilla
Campbell, Karen
deVore, Nikki
Fiore, Cara
George, Joe
Krasnicka, Barbara
Lee, Martha
Lee, Robert
Meysick, Karen
Trudell, Nicole
Vann, Willie
White, Janet
Wise, Robert
Menschik, David

We have two more reviewers – Milan Blake is now reviewing the hSBA assays and David Menschik is reviewing PMS information.

  1. Filing letter is in final review (done).  The filing letter is in final sign off stages.
  1. Major Deficiencies Identified
  1. Pertussis Assay Validation
  2. Diphtheria and Tetanus Assay Validation
  3. Performance Qualification for equipment and utilities
  4. Stability on polysaccharides
  5. Detailed SOPs for all the analytical methods involved in the preparation, characterization and quality control of the in-process intermediates,

The drug substance and drug product SOPs are not necessary, they can be removed from the major deficiencies letter.

  1. Deviations and corrective actions, container closure data, cleaning sterilization, depyrogenation and filling process validation data

This should be combined with “c”
There will be stats comments forthcoming.  There is concern over many protocol deviations for P13 involving two sites specifically, #44 and #50.  BIMO has picked 4 sites, and #44 is amongst them.

  1. Upcoming events (before calendar year end)
  1. no VRBPAC,
  2. Proprietary name review completed, - there will be another review 90 days before the action due date.
  3. PeRC/PREA – set date-  there were some questions on the timing of this.  It seems that this is too early. 
  4. lot release testing plan,
  5. BIMO scheduled, -  The sites have been picked and a draft plan is in the works.

There is quite a bit of concern over the timing of the final review due date.  The two inspections (BIMO and Compliance) will be performed in the Jan- Feb time frame.  If there are issues (i.e.483s), there is no time for the companies to respond (they have a 60 day response time) and to finalize the reviews with this due date of March 26, 2009.  Similar issues were raised for BIMO inspection.

  1. Documents – Reviews, memos, telecons, emails, meetings summaries, etc.
    1. All deadlines include uploading signed, certified pdf with attached Word doc into EDR.  If you have problems, please email david.schwab@fda.hhs.gov and cc me (cara.fiore@fda.hhs.gov).
    2. Send all original reviews, telecons, memos, etc to DVRPA (Cara Fiore)
  1. Communication with sponsor -  If anyone has any request for information, Cara can facilitate.  Please contact her.
  1. Committee assignments, Roles  and Responsibilities (SOPP 8401)

Al-Humadi, Nabil- Tox
Austin-Hansberry, Lori- OBE - reg coor
Bash, Margaret- Clin
Blake, Milan- hSBA Product
Burns, Drusilla- Assay Validation
Campbell, Karen- DPQ
Devore, Nicole- Prod coord trainee
Fiore, Cara- RPM
Freedberg, Daron- Product
George, Joseph- Facilities
Green, Dave                  Tox Chief (cc)
Gruber, Marion- Repro tox
Krasnicka, Barbara- Stat
Lee, Martha- Stat – assay
Lee, Robert- Product
Meysick, Karen- Assay Validation
Miller, Catherine- APLB
Pratt, Doug- Clin Chief (cc)
Richman, Paul- Branch Chief (cc)
Roecklein, Tina- Product Coord
Schwab, David- Elect. Integ
Sutkowski, Liz              (Branch Chief)
Sun, Div Dir  DVRPA (cc)
Trudel, Nicole- Facilities
Vann, Willie- CHAIR
White, Janet- BIMO
Wise, Robert- OBE
Menschik, David- PMS
 

  1. Major Due Dates are on Table below

Milestones

Date

STN Assignment

11Sept08

Committee Assignment

11Sept08

1st Committee Meeting

17Sept08

VRBPAC  Determination

12Oct08

Filing Meeting

>13Oct08

PeRC – schedule pres. If needed

27Oct08

Filing Action

>28Oct08

Deficiencies identified

>11Nov08

Draft Reviews Due/Mid Cycle review

25Jan09

VRBPAC planning meeting

26Nov08

PREA determination

25Jan08

Final Reviews Due

26Mar09

PMC to FDAAA Safety WG

06May08

Package to Branch Chief

27May09

Final Action Due Date

29Jun09

Action Package Posting

01Jul09

Monthly Meetings (Team)

Every Month

IOD Monthly Update (WV/CF)

Every Month

  1. November Meeting – November 19th (Wednesday) 3-4 pm – appt to be sent out
  1. December Meeting – December 17th (Wednesday) 3-4 pm tentative.
  1. Questions/Comments/Concerns?