Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Prevnar 13
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Memoranda/Reviews
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Summary Basis for Regulatory Action - Prevnar 13 (PDF - 167KB)Bioassay Statistical Review - December 6, 2009 - Prevnar 13 - Clinical Review of Biologics License Application for Prevnar 13 - February 17, 2010 (PDF - 1.1MB)
Please note the above document was originally posted with the incorrect year in the date. The corrected date is in the current document. DMPQ Review - Prevnar 13 (PDF - 325KB)Filing Meeting Memo - April 29, 2009 - Prevnar 13 - Indications and Usage Memo - February 19, 2010 - Prevnar 13
Please note the above document was originally posted with the incorrect year in the date. The corrected date is in the current document. Internal Mid-Cycle Review Meeting - June 30, 2009 - Prevnar 13 Meeting Summary - January 22, 2010 - Prevnar 13 Meeting Summary - September 1, 2009 - Prevnar 13 (PDF - 59KB)Meeting Summary - July 28, 2009 - Prevnar 13 Memo on Amendment for BLA STN 125324/0.50 Minutes of Internal Meeting - July 20, 2009 - Prevnar 13 Minutes of Internal Meeting - June 8, 2009 - Prevnar 13 Post-Marketing Commitment, Revised Protocol Template and Revised Specifications - Prevnar 13 Record of Internal Labeling Meeting 1 - May 27, 2009 - Prevnar 13 Response to Comment on Bioassays - December 17, 2009 - Prevnar 13 Review of Drug Substance and Drug Product Analytical Procedures - Prevnar 13 (PDF - 129KB)Review of Manufacturing Process - Prevnar 13 (PDF - 116KB)Review of Pertussis Assays - July 21, 2009 - Prevnar 13 Review of the Post Marketing Plans (PMP) for Prevnar 13™ (PDF - 129KB)Review of Serology Methodology - Prevnar 13 (PDF - 100KB)Review of Validation Studies - February 3, 2010 - Prevnar 13 Sponsor Response to FDA letter - May 5, 2009 - Prevnar 13 (PDF - 29KB)Statistical Review and Evaluation - Prevnar 13 (PDF - 1.1MB)Toxicology Review - Prevnar 13 (PDF - 3.3MB)
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Administrative Documents
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.
Letter - Proprietary Name Review - Prevnar 13 Letter - Acknowledgement of Filing - Prevnar 13 Letter - Filing Review - Prevnar 13 Letter - Major Amendment Submission - Prevnar 13 Record of Telephone Conversation - February 23, 2010 - Prevnar 13 Record of Telephone Conversation - January 13, 2010 - Prevnar 13 Record of Telephone Conversation - January 26, 2010-2 - Prevnar 13 Record of Telephone Conversation - January 26, 2010-1 - Prevnar 13 Record of Telephone Conversation - January 11, 2010 - Prevnar 13 Record of Telephone Conversation - January 7, 2010-1 - Prevnar 13 Record of Telephone Conversation - January 7, 2010-2 - Prevnar 13 (PDF - 56KB)Record of Telephone Conversation - January 4, 2010 - Prevnar 13 Record of Telephone Conversation - February 18, 2010 - Prevnar 13 (PDF - 31KB)Record of Telephone Conversation - February 8, 2010 - Prevnar 13 (PDF - 61KB)Record of Telephone Conversation - February 5, 2010 - Prevnar 13 Record of Telephone Conversation - December 22, 2009 - Prevnar 13 Record of Telephone Conversation - December 17, 2009 - Prevnar 13 Record of Telephone Conversation - December 16, 2009 - Prevnar 13 Record of Telephone Conversation - December 11, 2009 - Prevnar 13 Record of Telephone Conversation - December 10, 2009 - Prevnar 13 Record of Telephone Conversation - December 8, 2009 - Prevnar 13 Record of Telephone Conversation - December 3, 2009-1 - Prevnar 13 Record of Telephone Conversation - December 3, 2009-2 - Prevnar 13 Record of Telephone Conversation - December 2, 2009 - Prevnar 13 Record of Telephone Conversation - December 1, 2009 - Prevnar 13 Record of Telephone Conversation - November 25, 2009 - Prevnar 13 Record of Telephone Conversation - November 24, 2009 - Prevnar 13 Record of Telephone Conversation - November 20, 2009 - Prevnar 13 Record of Telephone Conversation - October 21, 2009 - Prevnar 13 Record of Telephone Conversation - October 15, 2009-2 - Prevnar 13 Record of Telephone Conversation - October 15, 2009-1 - Prevnar 13 Record of Telephone Conversation - October 7, 2009 - Prevnar 13 Record of Telephone Conversation - October 6, 2009 - Prevnar 13 Record of Telephone Conversation - October 1, 2009 - Prevnar 13 Record of Telephone Conversation - September 29, 2009 - Prevnar 13 Record of Telephone Conversation - September 25, 2009 - Prevnar 13 Record of Telephone Conversation - September 24, 2009 - Prevnar 13 Record of Telephone Conversation - September 22, 2009 - Prevnar 13 Record of Telephone Conversation - September 19, 2009 - Prevnar 13 Record of Telephone Conversation - September 17, 2009 - Prevnar 13 Record of Telephone Conversation - September 16, 2009-2 - Prevnar 13 Record of Telephone Conversation - September 16, 2009-1 - Prevnar 13 Record of Telephone Conversation - September 11, 2009 - Prevnar 13 Record of Telephone Conversation - September 3, 2009 - Prevnar 13 Record of Telephone Conversation - August 31, 2009 - Prevnar 13 Record of Telephone Conversation - August 19, 2009 - Prevnar 13 Record of Telephone Conversation - August 7, 2009 - Prevnar 13 Record of Telephone Conversation - August 6, 2009 - Prevnar 13 Record of Telephone Conversation - August 5, 2009 - Prevnar 13 Record of Telephone Conversation - July 24, 2009 - Prevnar 13 Record of Telephone Conversation - July 23, 2009 - Prevnar 13 Record of Telephone Conversation - July 21, 2009 - Prevnar 13 Record of Telephone Conversation - July 17, 2009 - Prevnar 13 Record of Telephone Conversation - July 1, 2009 - Prevnar 13 Record of Telephone Conversation - June 30, 2009 - Prevnar 13 Record of Telephone Conversation - June 18, 2009 - Prevnar 13 Record of Telephone Conversation - June 19, 2009 - Prevnar 13 Record of Telephone Conversation - June 15, 2009 - Prevnar 13 Record of Telephone Conversation - June 12, 2009 - Prevnar 13 Record of Telephone Conversation - June 5, 2009 - Prevnar 13 Record of Telephone Conversation - May 29, 2009 - Prevnar 13 Record of Telephone Conversation - May 21, 2009 - Prevnar 13 Record of Telephone Conversation - May 20, 2009-2 - Prevnar 13 Record of Telephone Conversation - May 20, 2009-1 - Prevnar 13 Record of Telephone Conversation - May 11, 2009 - Prevnar 13 Record of Telephone Conversation - May 8, 2009 - Prevnar 13 Record of Telephone Conversation - May 5, 2009 - Prevnar 13 Record of Telephone Conversation - May 1, 2009-1 - Prevnar 13 Record of Telephone Conversation - May 1, 2009-2 - Prevnar 13 Record of Telephone Conversation - April 30, 2009- Prevnar 13 Record of Telephone Conversation - April 27, 2009 - Prevnar 13
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