Vaccines, Blood & Biologics
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Approval History, Letters, Reviews and Related Documents - Spherusol
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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.
Pharmacovigilance Review Memo, July 29, 2011 - Spherusol (PDF - 37KB)Allermed BLA Memorandum, June 22, 2011 - Spherusol (PDF - 36KB)Clinical Review, June 27, 2011 - Spherusol (PDF - 293KB)Memorandum, June 16, 2011 - Spherusol Memorandum, June 1, 2011 - Spherusol Memorandum, May 11, 2011 - Spherusol (PDF - 84KB)Minutes of Meeting, March 23, 2011 - Spherusol Meeting Summary, February 11, 2011 - Spherusol (PDF - 30KB)Internal Meeting Summary, January 11, 2011 - Spherusol (PDF - 26KB)Minutes of Meeting, October 18, 2010 - Spherusol Summary Of Internal Meeting, June 29, 2010 - Spherusol Clinical Review, March 5, 2010 - Spherusol (PDF - 261KB)Memorandum, January 25, 2010 - Spherusol (PDF - 28KB)Mid-Cycle Review Memorandum, January 6, 2010 - Spherusol (PDF - 108KB)Internal Meeting Minutes, November 17, 2009 - Spherusol Internal Meeting Minutes, November 2, 2009 - Spherusol Mid-Cycle Review Meeting Minutes, October 19, 2009 - Spherusol Bioresearch Monitoring Mid-cycle Review Memo, October 19, 2009 - Spherusol Review Memorandum, August 19, 2009 - Spherusol Review Committee Meeting Summary, July 7, 2009 - Spherusol Review Memorandum, July 6, 2009 - Spherusol Pre-Filing Clinical Staff Meeting Agenda, July 2, 2009 - Spherusol BIMO Filing Memo, July 01, 2009 - Spherusol Review Memorandum, June 18, 2009 - Spherusol Incomplete Response Letter - Spherusol Unacceptable PN Letter - Spherusol Filing Notification Letter - Spherusol Filing Memorandum - Spherusol - Review of Response Memorandum (PDF - 22KB)
Pharmacovigilance Review of Sponsor's Response to CR Letter - Spherusol Incomplete Response Memorandum - Spherusol BLA Statistical Review and Evaluation - Spherusol (PDF - 115KB)Letter Response to BLA - Spherusol (PDF - 134KB)Filing Review Letter - Spherusol BLA Statistical Review and Evaluation Addendum - Spherusol (PDF - 162KB)Incomplete Response Letter(2) - Spherusol (PDF - 75KB)Statistical Review and Evaluation(2) - Spherusol (PDF - 295KB)Review Memorandum - Spherusol (PDF - 93KB)Filing Memorandum(2)- Spherusol
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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.
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