Memoranda/Reviews

• Summary Basis for Regulatory Action - Hiberix
• Clarification Memo Regarding Post-Marketing Required Study - July 9, 2009 - Hiberix
• Clinical Review - July 8, 2009 - Hiberix (PDF - 934KB)
• Confirmation Memo on BIMO Inspections - March 30, 2009 - Hiberix
• First Committee Meeting - March 31, 2009 - Hiberix
• Memo - June 26, 2009 - Hiberix
• Mid-Cycle Review Meeting - May 14, 2006 - Hiberix
• Pharmacovigilance Plan Review - March 27, 2009 - Hiberix
• Review Memo - August 5, 2009 - Hiberix
• Review Memo - July 31, 2009 - Hiberix
• Review Memorandum - June 22, 2009 - Hiberix
• Review of Drug Product Information - September 16, 2009 - Hiberix
• Product Review Memo for BLA Supplement - Hiberix, July 30, 2009 (PDF - 295KB)
• Review of Drug Substance and Drug Product Analytical Procedures - July 17, 2009 - Hiberix
• Review of Proposed Container and Package Labeling - July 14, 2009 - Hiberix
• Review of Proposed Container and Package Labeling - May 13, 2009 - Hiberix
• Review of Proposed Proprietary Name - May 19, 2009 - Hiberix
• Review of Serology Methodology - July 10, 2009 - Hiberix
• Threshold Pertussis Antibody Levels Memo - May 27, 2009 - Hiberix
• Statistical Review and Evaluation - Hiberix, March 17, 2009 (PDF - 643KB)

Administrative Documents

• Officer/Employee List - Hiberix

Correspondence

• CMC Comments - June 29, 2009
  CMC Comments related to Hiberix Package Insert.
• Committee Filing Meeting - April 6, 2009
  Summary of filing meeting for STN 125347.
• Letter - Potential Review Issues - Hiberix Potential review issues related to Hiberix biologics license application.
• Letter - Study Hib-097 Review - Hiberix Comments and requests for information regarding proposed study Hib-097.
• Letter - Study-097 - Hiberix Comments and request for information regarding revised concept protocol for Study HIB-097.
• Record of E-mail Communication 2 - July 14, 2009
  Additional comments related to the revised PI submitted July 10, 2009.
• Record of E-mail Communication 1 - July 14, 2009
  Comments to the revised label provided by GSK on July 10, 2009.
• Record of Telephone Conversation - July 30, 2009
  Dialogue about revisions to the list of PMCs
• Record of Telephone Conversation - June 26, 2009
  Comments regarding the PI.
• Record of Telephone Conversation - May 26, 2009 - Hiberix
  Discussion of clarification to questions pertaining to the pharmacovigilence plan.
• Record of Telephone Conversation - May 19, 2009 - Hiberix
  Request for SOPs, reagents and the required samples for testing in-support for BLA.
• Record of Telephone Conversation - April 20, 2009 - Hiberix
  Request for SOPs, reagents and the required samples for testing in-support for BLA.
• Teleconference Memorandum - July 16, 2009
  Hiberix BLA STN 125347—Package Insert.
• Teleconference Memorandum - July 9, 2009
  Request for clarification regarding sponsor’s response to July 8, 2009 telecon.
• Teleconference Memorandum - July 8, 2009
  Request for clarification regarding Section 6.1 of Hiberix package insert sent by Email 7/8/09.

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