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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Filing Meeting/Filing Action Summary - Agriflu, August 28, 2008

STN 125297/0

Agenda:

  1. Determine filing status of Agrippal 125297/0
  2. Determine deficiencies identified
  3. Discuss draft/final review completion dates
  4. Schedule Mid-Cycle Review
  5. Other discussion items

Milestones:

Application Received: July 11, 2008 (completed)

Committee Assignment July 21, 2008 (completed)

1st Committee Meeting July 28, 2008 (completed)

Filing Meeting August 22, 2008

Filing Action September 9, 2008

SOPP can be viewed at <http://www.fda.gov/cber/regsopp/8404.htm>.

Deficiencies Identified September 23, 2008

SOPP can be viewed at http://www.fda.gov/cber/regsopp/84013.htm. Letter template can be viewed at [high b(2)]

First Action Due May 11, 2009

 

Meeting Date: August 22, 2008

Meeting Attendees:  

Filing Determination:    

Goal: Communicate filing determination and deficiency identified in a single letter by the action due date of September 9th, 2008.

Deficiencies Identified:

  1. Labeling:
  1. Package Insert: LS (all) MB (all), AC (all), VP (all), JP (all), IB (all)
  2. Containers and Packaging:  AC, JP, VP

As of our meeting no deficiencies have yet been identified.

 

3. CMC: IB, PA, RG

Environmental Assessment/Categorical Exclusion-PA

As of our meeting no deficiencies have yet been identified. There were some questions posed by IB as to the temperatures and times used for adventitious agent testing and some question about the conditions used for inactivation. The -b(4)_ assay was once again discussed as it had been during the pre-BLA meeting.  None of the questions posed could lead to any filing issues.

 

4.  Nonclinical:  DG, MG

As of our meeting no deficiencies have yet been identified.

 

5. Clinical:

Pivotal, non-pivotal and supporting clinical studies, Pharmacovigilance plan – MB, PR, TL 

There was a question as to who should review the clinical immunogenicity data and it was determined that MB and IB will review the data. There were no deficiencies identified that would prevent filing the BLA.

 

6. Electronic Integrity-VP, JP

Additional information:

Financial disclosure and due diligence.

Other Discussion Items:

Draft Review Completion:

Draft reviews completed by mid-cycle – December 11, 2008.

Completed and signed off reviews due by March 31, 2009.

(AD:  May 11, 2009)-Approval package to leadership by April 11, 2009.

2nd committee meeting (mid-cycle) to be scheduled for December 11, 2008.

CBER:OVRR:DVRPA:

File: