Memorandum/Reviews

• Summary Basis for Regulatory Action - Pentacel
• Clinical Review (PDF - 1.4MB)
• Evaluation of Proposed Proprietary Name - Pentacel
• Immunogenicity Review - Pentacel (PDF - 1.5MB)
• Recommendations Regarding Request for Partial Waiver of Pediatric Studies
• Statistical Review and Evaluation (PDF - 188KB)
• Surveillance for Rates of Hib Disease Among Persons Aged 0-4 Years Receiving Pentacel or Other Hib Vaccines (PDF - 374KB)
• Surveillance for Rates of Pertussis Disease Among Persons Aged 0-4 Years Receiving Pentacel or Other Pertussis Vaccines (PDF - 279KB)
• 5/20/2008 Review Memo
• 2/14/2007 Review Memo
• Review of Biologics Application Amendment - Pentacel, February 20, 2007 (PDF - 235KB)
• Review of BLA - Pentacel, February 26, 2007 (PDF - 222KB)
• Review Memo - Pentacel, June 8, 2007 (PDF - 197KB)
• Review of Methods for Pertussis Clinical Serology - Pentacel, June 29, 2007 (PDF - 475KB)
• Post Licensure Safety Surveillance Study of Routine Use - Pentacel, May 18, 2007 (PDF - 269KB)
• Product Review of Haemophilus Component and Serology - Pentacel, February 9, 2007 (PDF - 420KB)
• Review of CMC and Serology of Diphtheria and Tetanus Toxoids - Pentacel, February 28, 2007 (PDF - 241KB)
• Review of BLA - Pentacel, January 25, 2007 (PDF - 81KB)
• Review Memo - Pentacel, May 26, 2006 (PDF - 1.6MB)
• Review of Biologics License Application - Pentacel, March 27, 2006 (PDF - 235KB)
• Memorandum - Pentacel, April 7, 2006 (PDF - 431KB)
• Review of DMPQ Issues in the Response to CR Letter - Pentacel, November 27, 2006 (PDF - 368KB)
• Clinical Review Memo - Pentacel, January 29, 2007 (PDF - 475KB)

Administrative Documents

• Officer/Employee List - Pentacel

Correspondence

• 5/16/2008 Fax - Pentacel (PDF - 151KB)
• 9/11/2007 Telecon - Pentacel (PDF - 183KB)
• 6/7/2007 Letter-Pentacel
• 5/18/2007 Meeting - Pentacel (PDF - 194KB)
• 4/23/2007 Letter-Pentacel

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