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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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First Meeting - December 11, 2008

Meeting DATE/Time:   December 11, 2008     9:00AM
FROM:           Debbie Cordaro DBA/RPM
                      Kelly Lewis, DBA/RPM
RE:                 125329/0

Attendees:  Michael Kennedy, Debbie Cordaro, Kelly Lewis, Margaret Mikolajczyk, Pei Zhang, Evi Struble, Ann Gaines, Craig Zinderman, Tony Hawkins, Hon Sum Ko, Nisha Jain, Xue Lin, Lisa Stockbridge

 

SPONSOR:    BPL

 

Product:  IGIV 5%

 

Action Due date:  September 17, 2009

 

To:     125329/0 File

 

SUBJECT:     First Committee Meeting

 

Discussion:

  • The committee was reminded that this is the first US product from BPL.
  • The members were asked if they have received their portion of the submission to review the following had not received their documents:
    • Mary Lin had notified Debbie/Kelly that the SAS files were not in the EDR.  Debbie commented that DCC was notified and would be uploading additional CDs shortly.
    • Tony Hawkins stated that he was awaiting Module 5.  Debbie commented that it was just obtained and was being rerouted to him.
  • When asked if there was any background information about this file, the committee was informed that the pre-BLA meeting minutes are contained in Module 1 (1.6)

 

Action Items:

  • Debbie/Kelly will email Nisha Jain to discuss review by PeRC committee
  • Debbie/Kelly will check with Iftekhar Mahmood to see if data he needs to review is included in the SAS files
  • Michael Kennedy will check which committee needs to be consulted about Boxed Warnings
  • Michael Kennedy will prepare the document to justify a waiver for BPAC
  • Debbie/Kelly will call the firm for an update when the PNR will be submitted
  • Michael Kennedy will check with Chiang Syin to see if he has reviewed Module 3 and if any issues have been identified.

Michael Kennedy will review 610.62 and evaluate the labels for appropriate format, etc.

  • Debbie/Kelly will modify the review schedule to expand on the new FDAAA milestones.
  • Mike Kennedy will consult with Joe Quander about Lot Release protocol/testing plan
  • The committee members will review SOPP 8404 Refusal to File Procedures for BLA as it pertains to their section(s)  to prepare for the filing meeting
  • The committee members will prepare executive summaries of their midcycle review to be used in the Chair’s midcycle memorandum

The committee was reminded that under FDAAA we will now be expected to do our extensive label review approximately 2 weeks after the mid-cycle meeting.  The members were advised to begin their extensive editing of the label as soon as possible to be prepared to participate in the extensive labeling discussion.