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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Committee Filing Meeting - April 6, 2009

STN 125347 Committee Filing Meeting

Date:   April 6, 2009

Summary:

Filing meeting conducted via e-mail. The initital e-mail was sent April 2, 2009 and all available committee members responded by April 6, 2009. The unanimous decision was that the BLA may be filed.

APLB has reviewed the Proprietary Name Submission and determined that it is complete. The 90 day milestone (June 29, 2009) has been added to RMS-BLA.

DMPQ reviewers have presented a deficiency to the committee to be included in the Deficiencies Identified Letter:

Please provide container closure integrity PQ/validation data for the Container Closure System.  This data was not included in section 3.2.P.7 of your BLA submission.  Also, please include summary data of any extractables/leachables studies.

No other issues were discussed.

Milestones:

Application Received:March 17, 2009
Committee AssignmentMarch 24, 2009
1st Committee MeetingMarch 31, 2009
Filing Meeting  April 2, 2009 (via e-mail)
Filing Action/Deficiencies IdentifiedApril 16, 2009
Target Action Due Date:   

July 31, 2009

  
Committee Chair: Jay Slater, M.D.
  
Committee Members 
Clinical Reviwer/Labeling  Karen Farizo, M.D.
Product CMC/SerologyMustafa Akkoyunlu, M.D. Ph.D,
Product CMCScott Norris
Product CMCTina Roecklein
Facilities/DMPQJoseph George
Advertising/ Promotional LabelingMaryann Gallagher
Clinical Statistical Reviewer Ghideon Ghebregiorgis, Ph.D.
Epidemiology  David Menschik, M.D., MPH
DPQ/Lot Testing PlanRajesh Gupta, Ph.D.
Lot ReleaseJoe Quander III
BiMoChristine Drabick, MS
DVRPA ReviewerJoe Temenak, Ph.D.
  
RPMs/RC 
DVRPA Regulatory Project Mgr.  Jason Humbert
DBPAP Regulatory CoordinatorJennifer Bridgewater, MPH
  
  
 

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