Vaccines, Blood & Biologics
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Approval History, Letters, Reviews and Related Documents - MenHibrix
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Memorandum/Reviews
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Product Review Memo for BLA Supplement 125363, June 12, 2012 (PDF - 139KB)Clinical Review, June 7, 2012 - MenHibrix (PDF - 1.4MB)Review Memo, June 5, 2012 - MenHibrix (PDF - 94KB)CMC Review Memo, May 15, 2012 - MenHibrix Labeling Request Memorandum, May 14, 2012 - MenHibrix CR Response Review, May 13, 2012 - MenHibrix Product Review and Approval Memo, May 2, 2012 - MenHibrix (PDF - 89KB)Results Memo, April 25, 2012 - MenHibrix Pharmacovigilance Plan Review Addendum, April 24, 2012 - MenHibrix Final DBSQC Review Memo, April 20, 2012 - MenHibrix Serology Review Memo, April 16, 2012 - MenHibrix Proprietary Name Review Memo, April 10, 2012 - MenHibrix Label Review Memorandum, March 30, 2012 - MenHibrix Serology Review Memo, March 27, 2012 - MenHibrix Serology Review Memo, Additional comments, March 27, 2012 - MenHibrix Serology Review Memo, January 19, 2012 - MenHibrix Major Admendment Letter - MenHibrix Request for Categorical Exclusion Memo - MenHibrix Filing Memo, December 13, 2011 - MenHibrix Statistical Review and Evaluation, December 1, 2011 - MenHibrix RAC Letter - MebHibrix DPQ Review Memo, September 6, 2011 - MenHibrix CMC Review Memo, September 1, 2011 - MenHibrix Product Review Memo, August 29, 2011 - MenHibrix Clinical Review, August 26, 2011 - MenHibrix DPQ Review Memo, August 26, 2011 - MenHibrix (PDF - 97KB)Serology Review Memo, August 25, 2011 - MenHibrix (PDF - 126KB)Product Review Memo, August 25, 2011 - MenHibrix (PDF - 75KB)Statistical Review and Evaluation, April 15, 2011 - MenHibrix First Committee Meeting Memorandum, May 3, 2011 - MenHibrix Review Committee Assignment Memorandum, May 2, 2011 - MenHibrix Consult Review Memo - MenHibrix Clinical Review, June 3, 2010 - MenHibrix (PDF - 654KB)Summary BIMO Inspections, May 13, 2010 - MenHibrix (PDF - 30KB)Assay Review Memo, May 13, 2010 - MenHibrix Identity Test Results Memo, May 6, 2010 - MenHibrix Product Review Memo, May 5, 2010 - MenHibrix (PDF - 314KB)Serology Review Memo, May 5, 2010 - MenHibrix (PDF - 508KB)Product Review Memo, May 4, 2010 - MenHibrix (PDF - 166KB)Product Review Memo, May 04, 2010 - MenHibrix (PDF - 78KB)Product Review, May 3, 2010 - MenHibrix (PDF - 138KB)Product Review Memo, April 28, 2010 - MenHibrix (PDF - 170KB)CMC Review Memo, April 21, 2010 - MenHibrix Final Review, March 15, 2010 - MenHibrix BLA Supplement Review, February 4, 2010 - MenHibrix (PDF - 30KB)Mid-Cycle Review Memo, January 26, 2010 - MenHibrix IPV Review Memo, January 11, 2010 - MenHibrix Review Memo, January 11, 2010 - MenHibrix Assay Review Memo, January 7, 2010 - MenHibrix DBSQC Chemical Test Results Memorandum - MenHibrix Statistical Review and Evaluation - MenHibrix (PDF - 480KB)Statistical Review and Evaluation BLA - MenHibrix (PDF - 391KB)Zoster Studies Memorandum - MenHibrix Review of GlaxoSmithKline Biologicals Memorandum, October 23, 2009 - MenHibrix Review of Proposed Proprietary Name Memo, October 20, 2009 - MenHibrix Review of Container and Package Labeling Memo, October 20, 2009 - MenHibrix Proper Name Review Memorandum, September 2, 2009 - MenHibrix Proprietary Name Review Letter - MenHibrix Acknowledgement Letter, August 24, 2009 - MenHibrix Statistical Review and Evaluation, August 12, 2009 - MenHibrix (PDF - 92KB)Filing NDI Letter, MenHibrix Statistical Review and Evaluation, Amendment 12 - MenHibrix BLA Review revised - MenHibrix (PDF - 335KB)Response to CR Review Memo - MenHibrix (PDF - 80KB)Complete Review Letter - Menhibrix (PDF - 39KB)FAMA for Zoster Studies Memo - MenHibrix Complete Review Letter, June 11 version1 - MenHibrix (PDF - 66KB)Review Memo - MenHibrix (PDF - 125KB)Complete Response Letter - MenHibrix (PDF - 78KB)Final Review of GSK’s BLA Memo, MenHibrix (PDF - 166KB)Review Memo, Recommendations - MenHibrix (PDF - 98KB)OBE BLA Review Memo - MenHibrix
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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, June 1, 2012 - MenHibrix Record of Telephone Conversation, Storage Temps, June 1, 2012 - MenHibrix Record of Telephone Conversation, May 29, 2012 - MenHibrix Compliance Check Email, May 29, 2012 - MenHibrix Record of Telephone Conversation, May 25, 2012 - MenHibrix Record of Telephone Conversation, May 23, 2012 - MenHibrix Compliance Check Email, May 22, 2012 - MenHibrix Record of Telephone Conversation, May 18, 2012 - MenHibrix Clarification Request Email, May 15, 2012 - MenHibrix Record of Telephone Conversation, May 14, 2012 - MenHibrix Auxiliary label Email, May 10, 2012 - MenHibrix (PDF - 750KB)Lot Clearance Request Memo Email, May 9, 2012 - MenHibrix (PDF - 51KB)OVRR Lot Clearance Request Email, May 09, 2012 - MenHibrix Record of Telephone Conversation, May 7, 2012 - MenHibrix CBER Question on Kit Carton Email, May 4, 2012 - MenHibrix Record of Telephone Conversation, IR Comments, May 3, 2012 - MenHibrix Record of Telephone Conversation, May 3, 2012 - MenHibrix Record of Telephone Conversation, May 2, 2012 - MenHibrix Record of Telephone Conversation, April 24, 2012 - MenHibrix UNII Code Request Email, April 11, 2012 - MenHibrix Record of Telephone Conversation, April 4, 2012 - MenHibrix Record of Telephone Conversation, March 27, 2012 PM - MenHibrix Record of Telephone Conversation, March 27, 2012 - MenHibrix Record of Telephone Conversation, March 23, 2012 - MenHibrix Record of Telephone Conversation, March 22, 2012 - MenHibrix Record of Telephone Conversation, March 20, 2012 - MenHibrix Record of Telephone Conversation, February 23, 2012 - MenHibrix Record of Telephone Conversation, February 6, 2012 - MenHibrix Record of Telephone Conversation, January 17, 2012 - MenHibrix Monthly Meeting Summary, January 18, 2012 - MenHibrix Follow-up Discussion on GSK’s October Meeting Minutes, November 19, 2010 - MenHibrix Record of Telephone Conversation, December 12, 2011 - MenHibrix Record of Telephone Conversation, December 5, 2011 - MenHibrix Record of Telephone Conversation, November 30, 2011 - MenHibrix Record of Telephone Conversation, November 29, 2011 - MenHibrix Record of Telephone Conversation, November 25, 2011 - MenHibrix Record of Telephone Conversation, November 23, 2011 - MenHibrix Meeting Minutes, November 8, 2011 - MenHibrix Request GSK's Proposals, October 25, 2011 - MenHibrix Record of Telephone Conversation, October 19, 2011 - MenHibrix Record of Telephone Conversation, October 13, 2011 - MenHibrix Record of Telephone Conversation, October 13, 2011 PM - MenHibrix Record of Telephone Conversation, September 21, 2011 - MenHibrix Record of Email Receipt, September 16, 2011 - MenHibrix Record of Telephone Conversation, August 16, 2011 - MenHibrix Meeting Minutes, August 8, 2011 - MenHibrix (PDF - 48KB)GSK MenHiberix BLA Committee Email, August 05, 2011 - MenHibrix Review Committee Assignment, July 25, 2011 - MenHibrix Record of Telephone Conversation, July 15, 2011 - MenHibrix Mid-Cycle Meeting Minutes, July 11, 2011 - MenHibrix (PDF - 33KB)Record of Telephone Conversation, June 30, 2011 - MenHibrix Record of Telephone Conversation, June 23, 2011 - MenHibrix Record of Telephone Conversation, June 16, 2011 - MenHibrix (PDF - 96KB)Record of Telephone Conversation, June 6, 2011 - MenHibrix Record of Telephone Conversation, May 26, 2011 - MenHibrix (PDF - 13KB)Notification of no VRBPAC, May 11, 2011 - MenHibrix Pediatric Form Page, April 15, 2011 - MenHibrix (PDF - 143KB)Change in Review Committee Assignment, April 2, 2012 - MenHibrix Record of Telephone Conversation, March 11, 2011 - MenHibrix Record of Telephone or Email Communication, February 9, 2011 - MenHibrix Meeting Minutes, August 29, 2011 - MenHibrix (PDF - 33KB)Record of Telephone Conversation, January 18, 2011 - MenHibrix Sponsor calls, October 27, 2010 - MenHibrix Email Response to Sponsor, October 27, 2010 - MenHibrix Minutes of Telephone Conference, October 12, 2010 - MenHibrix Teleconference to Discuss Complete Response Item, October 6, 2010 - MenHibrix Telephone Conference Amendment Review Memorandum, June 21, 2010 - MenHibrix Record of Email Communication, June 21, 2010 - MenHibrix Record of Telephone Conversation, June 11, 2010 - MenHibrix Record of Telephone Conversation, May 3, 2010 - MenHibrix Record of Email Communication, April 20 -May 3, 2010 - MenHibrix Record of Email Communication, April 4, 2010 - MenHibrix Record of Email Communication, February 25, 2010 - MenHibrix Record of Telephone Conversation, February 9, 2010 - MenHibrix Record of Email Communication, February 4, 2010 - MenHibrix Record of Email Communication, February 3, 2010 - MenHibrix Record of Email Communication, February 2, 2010 - MenHibrix Record of Email Communication, February 2, 2010 AM - MenHibrix Record of Telephone Conversation, January 22, 2010 - MenHibrix Change in Review Committee Assignment, December 23, 2009 - MenHibrix Assay Reviewer Request Email, December 23, 2009 - MenHibrix Regarding Assay Reviewer Request Email, December 23, 2009 - MenHibrix Record of Communication, December 22, 2009 - MenHibrix Record of Telephone Conversation, December 10, 2009 - MenHibrix Record of Communication, December 9, 2009 - MenHibrix Record of Email Communication, December 7, 2009 - MenHibrix Record of Email Communication, December 2, 2009 - MenHibrix Record of Email Communication, October 21, 2009 - MenHibrix Record of Email Communication, October 30, 2009 - MenHibrix Monthly Meeting Summary, October 13, 2009 - MenHibrix Committee Filing Meeting, September 21, 2009 - MenHibr Committee Assignment, August 25, 2009 - MenHibrix Committee Assignment, September 9, 2009 - MenHibrix First Committee Meeting, September 8, 2009 - MenHibrix
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