Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Menveo
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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.
Clinical Review - January 31, 2011 - Menveo (PDF - 682KB)Statistical Review and Evaluation STN12530095 - Menveo (PDF - 620KB)Analytical Test Method Validation Report, February 15, 2010 - Menveo Bioresearch Monitoring Inspection Results, June 12, 2009 - Menveo Clinical Review for Proposed Indication Memo, January 28, 2010 - Menveo (PDF - 759KB)Complete Review of CMC-Product of BLA STN 125300, February 2, 2010 - Menveo Comments on Draft Clinical Study Protocol V59_34, December 14, 2009 - Menveo Complete Response Letter - Menveo Complete Review of CMC-Product of BLA STN 125300, April 4, 2009 - Menveo (PDF - 19KB)Complete Review of Product CMC for BLA STN 125300, January 12, 2010 - Menveo Filing Letter - Menveo Filing Meeting Memo, October 13, 2008 - Menveo Final Review Memo, March 25, 2009 - Menveo (PDF - 136KB)Memo - Comments on the assay validation of Diphtheria and Tetanus concomitant vaccines, January 15 2009 - Menveo Mid-Cycle Review, January 12, 2009 - Menveo Monthly Meeting, October 14, 2009 - Menveo Monthly Meeting, December 17, 2008 - Menveo Pharmacovigilance Plan Review, January 22, 2010 - Menveo Pharmacovigilance Plan Review Addendum - Menveo Response to August 21, 2009 Letter - Menveo Review of the Analytical Procedures, January 20, 2010 - Menveo (PDF - 149KB)Review Committee Meeting Summary, December 16, 2009 - Menveo Review Committee Meeting Summary, November 12, 2009 - Menveo Review of Novartis Vaccines and Diagnostics, Inc. BLA, June 24, 2009 - Menveo (PDF - 218KB)Review of pertussis assay validation for STN: 125300, March 6, 2009 - Menveo Review Committee Meeting Summary, January 20, 2010 - Menveo Review Committee Meeting, February 11, 2009 - Menveo Review of Novartis’ responses to the CR Letter Memo - Menveo Review Memo, Due Date - June 29, 2009 - Menveo (PDF - 141KB)Reproduction Toxicity Study Review, Menveo (PDF - 355KB)Statistical Review and Evaluation - Menveo (PDF - 435KB)Statistical Review and Evaluation (Revised Summary and Conclusions) - Menveo Toxicology Review of MenACWY as a Meningitis Vaccine Formulations - Menveo (PDF - 241KB)Filing Review, November 2, 2008 - Menveo
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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.
Telecon CMC, January 27, 2010 - Menveo Telecon, PVP Date, January 25, 2010 - Menveo Telecon PMC January 25, 2010 - Menveo Telecon Advice, January 8, 2010 - Menveo Telecon PVP, January 7, 2010 - Menveo Telecon Comments on PVP, December 23,2009 - Menveo Telecon - Drug Substance Testing, December14, 2009 - Menveo Telecon - 36 month dating and PVP plan, November 3, 2009 - Menveo Telecon - Leachable in stopper, October 15, 2009 - Menveo Telecon - Men A Standard, September 9, 2009 Telecon - PVP for Menveo, August 10, 2009 - Menveo Telecon - Information Request, June 24, 2009 - Menveo Telecon - Advice, June 11, 2009 - Menveo Telecon - Information Request, May 22, 2009- Menveo Telecon on Pharmacovigilance - May 13, 2009 - Menveo Telecon - Information Request, May 4, 2009 - Menveo Telecon - Information Request, May 1, 2009 - Menveo Email - PREA Request, April 6, 2009 - Menveo Teleconference Memo, March 23, 2009 - Menveo Email - 125300 PVP Comments, January 29, 2009 - Menveo Email - 125300 Comment and Question, January 27, 2009 - Menveo Email - BLA questions: DI, Linearity and final container, January 7, 2009 - Menveo
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