Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Agriflu
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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.
BLA Review - Agriflu, December 2, 2009 (PDF - 675KB)BLA Amendment Review Memo - Agriflu, November 28, 2009 Summary Basis of Regulatory Action (SBRA) - Agriflu, November 25, 2009 (PDF - 267KB)Re-evaluation of the Proposed Name Review Memorandum - Agriflu, October 20, 2009 – Review of Drug Substance and Drug Product Analytical Procedures Memo - Agriflu, October 9, 2009 (PDF - 65KB)Additional Comments to CMC Review - Agriflu, October 6, 2009 Clinical Review - Agriflu (PDF - 77KB)Statistical Review - Agriflu (PDF - 53KB)Chemistry, Manufacturing, and Controls - Agriflu, August 14, 2009 (PDF - 255KB)Acknowledgement Letter - Agriflu, July 21, 2008 April 27, 2009 Complete Response to FDA Action Letter - Agriflu, June 10, 2009 (PDF - 48KB)Proprietary Name Review Request - Agriflu, May 13, 2009 (PDF - 285KB)Statistical Review and Evaluation - Agriflu, May 29, 2009 (PDF - 48KB)Review Memo - Agriflu, May 11, 2009 (PDF - 145KB)Reproduction Toxicity Study Review - Agriflu, May 8, 2009 Review of Novartis’ Response to the Complete Response - Agriflu, April 27, 2009 (PDF - 85KB)Bioresearch Monitoring Final Review Memo - Agriflu, March 20, 2009 (PDF - 51KB)Review of Drug Substance and Drug Product Analytical Procedures - Agriflu, March 6, 2009 (PDF - 94KB)OBE/DE Review Memo - Agriflu, February 27, 2009 (PDF - 396KB)Re-evaluation of Proposed Proprietary Name - Agriflu, February 24, 2009 Statistical Review and Evaluation - Agriflu, January 30, 2009 (PDF - 84KB)Comments on Draft Product Labeling Review Memo - Agriflu, January 29, 2009 (PDF - 85KB)Response to CBER Comments Review - Agriflu, January 19, 2009 (PDF - 200KB)Reproduction Toxicity Study Review - Agriflu, November 3, 2008 (PDF - 628KB)Filing Meeting/Filing Action Summary - Agriflu, August 28, 2008 Committee Meeting Minutes - Agriflu, July 28, 2008 (PDF - 35KB)Statistical Review and Evaluation - Agriflu, July 10, 2008 Toxicology Review of a Two Dose Intramuscular Toxicity Study - Agriflu (PDF - 326KB)Statistical Review and Evaluation BLA - Agriflu, July 10, 2008 (PDF - 148KB)Letter - Agriflu NDI Letter - Agriflu Establishment Evaluation Request - Agriflu, October 30, 2008 (PDF - 29KB)
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Correspondence
Record of Telephone Conversation - Agriflu, November 24, 2009 Record of Telephone Conversation - Agriflu, November 23, 2009 Record of Telephone Conversation - Agriflu, November 6, 2009 Memo of Telecon with Novartis - Agriflu, November 3, 2009 Memo of Telecon with Novartis - Agriflu, October 1, 2009 Record of Telephone Conversation - Agriflu, September 22, 2009 Record of Telephone Conversation Requested Dates - Agriflu, September 21, 2009 Record of Telephone Conversation Corrected Dates for Pediatric Studies - Agriflu, September 21, 2009 Record of Telephone Conversation Corrected Dates for Pediatric Studies Submitted to PeRC - Agriflu, September 21, 2009 Record of Telephone Conversation - Agriflu, September 4, 2009 Record of Telephone Conversation - Agriflu, August 27, 2009 Record of Telephone Conversation - Agriflu, August 18, 2009 Record of Telephone Conversation - Agriflu, August 14, 2009 Record of Telephone Conversation - Agriflu, July 31, 2009 Record of Telephone Conversation - Agriflu, July 27, 2009 Record of Telephone Conversation - Agriflu, July 9, 2009 Record of Telephone Conversation - Agriflu, July 8, 2009 Record of Telephone Conversation Advice to Novartis - Agriflu, July 6, 2009 Record of Telephone Conversation Discussion of Issues - Agriflu, July 6, 2009 Record of Telephone Conversation - Agriflu, June 8, 2009 Record of Telephone Conversation - Agriflu, January 30, 2009 Record of Telephone Conversation - Agriflu, January 12, 2009 Record of Telephone Conversation - Agriflu, December 8, 2009 Record of Telephone Conversation - Agriflu, November 17, 2008 Record of Telephone Conversation - Agriflu, November 12, 2008 Record of Telephone Conversation - Agriflu, October 29, 2008 Record of Telephone Conversation - Agriflu, October 17, 2008 Record of Telephone Conversation - Agriflu, September 23, 2008 Record of Telephone Conversation - Agriflu, September 4, 2008 Record of Telephone Conversation - Agriflu, July 30, 2008
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