Vaccines, Blood & Biologics
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Approval History, Letters, Review, and Related Documents - Flublok
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Reviews/Memorandums
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Clinical Review, January 16, 2013 - Flublok (PDF - 1.6MB)CMC Review, January 15, 2012 - Flublok (PDF - 282KB)Cell Substrate Review Memo, January 14, 2013 - Flublok (PDF - 127KB)Closeout Memo - Flublok Acknowledgment of Filing Letter - Flublok Statistical Review and Evaluation - Flublok (PDF - 503KB)Review Memo, August 13, 2008 - Flublok (PDF - 130KB)Review of Amendment 52 Memo, Flublok Review of Amendment 53 Memo, Flublok Information Request Memo - Flublok Review of Results Memo, November 11, 2010 - Flublok Interim Report on Process Validation Memo - Flublok CMC Review, January 25, 2010 - Flublok Complete Response Letter - Flubok Statistical Review, December 18, 2009 - Flubok Review Memo, December 14, 2009 - Flublok (PDF - 609KB)Review of IR Letter Responses Reproduction Toxicity Study Review, September 18, 2009 - Flublok (PDF - 193KB)Review of IR Letter Responses submitted August 24, 2009 - Flublok Review of CR - Flublok (PDF - 83KB)BLA Review, November 10, 2008 - Flublok (PDF - 205KB)Complete Response Letter - Flublok (PDF - 201KB)Review of Biologics License Application (BLA) (PDF - 296KB)Review of Amendment 57 Memo - Flublok (PDF - 296KB)
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Administrative
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
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Correspondence
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Record of Telephone Conversation, January 17, 2012 - Flublok Record of Telephone Conversation, January 10, 2013 - Flublok Record of Telephone Conversation, January 9, 2013 - Flublok Record of Telephone Conversation, January 9, 2013 am - Flublok Addendum: Phase 4 Observational Safety Study - Flublok (PDF - 128KB)Record of Telephone Conversation, December 14, 2012 - Flublok Record of Telephone Conversation, December 13, 2012 - Flublok Record of Telephone Conversation, November 30, 2012 - Flublok Record of Telephone Conversation, November 9, 2012 - Flublok Record of Telephone Conversation, October 19, 2012 - Flublok Midcycle Meetings Minutes Final, October 16, 2012 - Flublok Record of Telephone Conversation, October 5, 2012 - Flublok Record of Telephone Conversation, September 28, 2012 - Flublok Record of Telephone Conversation, September 11, 2012 - Flublok Record of Telephone Conversation, September 9, 2012 - Flublok (PDF - 159KB)Record of Telephone Conversation, August 8, 2012 - Flublok Record of Telephone Conversation, August 1, 2012 - Flublok Resubmission Acknowledgment Letter, July 30, 2012 - Flublok Record of Telephone Conversation, April 28, 2012 - Flublok Record of Telephone Conversation, April 6, 2012 - Flublok Record of Telephone Conversation, April 3, 2012 - Flublok Record of Telephone Conversation, March 02, 2012 - Flublok Record of Telephone Conversation, December 8, 2011 - Flublok Record of Telephone Conversation, December 7, 2011 - Flublok Record of Telephone Conversation, November 10, 2011 - Flublok Record of Telephone Conversation, November 8, 2011 - Flublok Record of Telephone Conversation, October 21, 2011 - Flublok Record of Telephone Conversation, May 27, 2011 - Flublok Clarification Regarding H1 rHA SRID Assay Email, May 05, 2011 - Flublok Record of Telephone Conversation, April 27, 2011 - Flublok - Record of Telephone Conversation, February 22, 2011 - Flublok
Record of Telephone Conversation, January 7, 2011 - Flublok Meeting Minutes, December 10, 2010 - Flublok (PDF - 85KB)Record of Telephone Conversation, July 27, 2010 - Flublok Meeting Minutes, April 12, 2010 - Flublok (PDF - 136KB)PSC Type C Meeting Questions, April 9, 2010 - Flublok Responses to Complete Response Letter Memo, January 21, 2010 - Flublok Meeting Minutes, January 13, 2010 - Flublok Record of Telephone Conversation, December 16, 2009 - Flublok Meeting Minutes, November 30, 2009 - Flublok Minutes of Internal Meeting, November 23, 2009 - Flublok Information Request Email, November 06, 2009 - Flublok Request for samples for in-support testing Email, October 29, 2009 - Flubok Meeting Minutes, October 23, 2009 - Flublok (PDF - 113KB)Record of Telephone Conversation, October 8, 2009 - Flublok Meeting Minutes, October 7, 2009 - Flublok Record of Telephone Conversation, October 6, 2009 - Flublok Meeting Minutes, October 6, 2009 - Flublok Information Request, October 1, 2009 - Flublok (PDF - 66KB)Record of Telephone Conversation, October 1, 2009 - Flublok Record of Telephone Conversation, August 14, 2009 - Flublok Record of Telephone Conversation, July 30, 2009 - Flublok (PDF - 95KB)Mid Cycle Meeting Summary, July 13, 2009 - Flublok (PDF - 81KB)Record of Telephone Conversation, June 19, 2009 - Flublok Record of Telephone Conversation, June 9, 2009 - Flublok Record of Telephone Conversation, May 27, 2009 - Flublok Major Amendment letter - Flublok Record of Telephone Conversation, July 15, 2008 - Flublok Record of Telephone Conversation, June 12, 2008 - Flublok Class 2 Action Letter - Flublok Record of Telephone Conversation, May 29, 2008 - Flublok First Committee Meeting, May 2, 2008 - Flublok Record of Telephone Conversation, July 16, 2008 - Flublok
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