Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Intersol
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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.
CMC Review InterSol Platelets Additive Solution - Intersol (PDF - 112KB)Comments on Response to CR (NDA) - Intersol (PDF - 101KB)First Committee Meeting Summary for BN080041/0 Memorandum - Intersol, September 17, 2008 Statistical Review and Evaluation - Intersol BN080041-InterSol Platlet Additive Solution CMC Mid Cycle Review Memo - Intersol Review of Responses to CMC Issues for BN080041 - Intersol Internal Memo - Intersol, November 24, 2009 (PDF - 87KB)NDA 080041, Amendment 011 - Review of March 18, 2009 Response to Information on Stability Testing - Intersol Scientific Evaluation and Review Memorandum - Intersol, July 31, 2008 (PDF - 84KB)Scientific Evaluation and Review Intersol - July 31, 2008 (PDF - 107KB)Memo Filing Meeting Memorandum - Intersol, October 1, 2008 Statistical Review - Intersol, March 3, 2009 (PDF - 169KB)Comments on Response to IR (NDA) - Intersol, June 4, 2009 (PDF - 91KB)Mid Cycle Review Memo (NDA) - Intersol, June 4, 2009 (PDF - 152KB)Bioresearch Monitoring Inspection Results Memorandum - Intersol, June 22, 2009 Statistical Review and Evaluation - Intersol, July 24, 2009 (PDF - 58KB)Internal Review Meeting Memorandum - Intersol, August 28, 2009 (PDF - 64KB)Re-evaluation of Proposed Proprietary Name InterSol Solution Memorandum - Intersol, October 13, 2009 Final Review Memo (NDA) - Intersol, December 12, 2009 (PDF - 177KB)Review Memorandum - Intersol, July 31, 2008 (PDF - 317KB)Internal Memorandum - Intersol, January 28, 2009 (PDF - 52KB)Internal Memo - Intersol, January 28, 2009 (PDF - 73KB)
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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.
FDA Comments On The ‘Clinical and Statistics’ Section In Fenwal’s May 12 2009 Response to April 6, 2009 CR Letter - Intersol PNA Letter - Intersol Resubmission Acknowledgement Letter Class 2 - Intersol Incomplete Response to CR Letter - Intersol Filing Letter - Intersol Acknowledgement Letter - Intersol Telecon - Intersol, October 15, 2009 (PDF - 99KB)Telecon - Intersol, October 7, 2009 (PDF - 39KB)Acknowledgement Letter - Intersol FDA's Justification of PMS Letter - Intersol, September 8, 2008 Fax regarding BN080041 - Intersol, January 23, 2009 (PDF - 294KB)Fax regarding BN080041, Intersol - February 11, 2009 (PDF - 37KB)Fax Regarding BN080041 - Intersol, February 11, 2009 (PDF - 38KB)Fax Regarding BN080041 - Intersol, February 23, 2009 (PDF - 39KB)Fax Regarding BN080041 - Intersol, July 20, 2009 (PDF - 36KB)Fax Regarding BN080041 - Intersol, July 28, 2009 (PDF - 70KB)Fax Regarding BN080041 - Intersol, August 12, 2009 (PDF - 33KB)Statistical Review and Evaluation Letter - Intersol, August 18, 2009 Fax regarding BN080041 - Intersol, August 24, 2009 (PDF - 39KB)Fax Regarding BN080041 - Intersol, September 8, 2009 (PDF - 41KB)FDA Response to Fenwal's September 17, 2009 Document - Intersol (PDF - 26KB)Fax Regarding BN080041 - Intersol, September 18, 2009 (PDF - 48KB)Fax Regarding BN080041 - Intersol, September 18, 2009 (PDF - 38KB)FDA Comments on Fenwal's November 12, 2009 PMR/PMC Proposal - Intersol Fax Regarding BN080041 - Intersol, November 19, 2009 (PDF - 44KB)Telecon - Intersol, August 11, 2009 (PDF - 63KB)Telecon 2 - Intersol, October 15, 2009 (PDF - 61KB)Telecon - Intersol, November 3, 2009 (PDF - 80KB)
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