Vaccines, Blood & Biologics
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Approval History, Letters, Review, and Related Documents - Octaplas
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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 Plan Review, January 7, 2013 - Octaplas (PDF - 1.1MB)Final Review of Stability and Viral Safety information Memo, December 2012 - Octaplas (PDF - 229KB)Action Review Memo, December 24, 2012 - Octaplas (PDF - 311KB)Requesting a Proprietary Name Review Letter - Octaplas Categorization of 62 serious unlisted ADRs for Octaplas Final Review Memo, October 2012 - Octaplas (PDF - 328KB)Bioresearch Monitoring Mid-Cycle Review Memo, May 16, 2012 - Octaplas Filing Letter - Octaplas Filing Memo - Octaplas DMPQ Review Memo - Octaplas (PDF - 451KB)Clinical Review Memo - Octaplas (PDF - 1.6MB)Final Statistical Review and Evaluation - Octaplas (PDF - 164KB)Pharmacology Toxicology Review, October 3, 2012 - Octaplas Pharmacology Toxicology Review recd July 5, 2012 - Octaplas (PDF - 118KB)Mid-Cycle Statistical Review and Evaluation - Octaplas (PDF - 266KB)Mid-cycle Review - Octaplas (PDF - 231KB)Mid-cycle review of Original BLA - Octaplas (PDF - 273KB)Pharmacology/Toxicology Review, December 22, 2011 (PDF - 418KB)Pharmacology and Toxicology Review - Octaplas (PDF - 236KB)
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Administrative Documents
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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Correspondence
Persons with disabilities having problems accessing any of these files may call CBER's Consumer Affairs Branch 301-827-1800 for assistance.
Biologics license application (BLA) Amendment Letter - Octaplas Record of Telephone Conversation, November 5, 2012 - Octaplas Record of Telephone Conversation, October 22, 2012 - Octaplas Extension of Action Due Date Email, October 17, 2012 -Octaplas Record of Telephone Conversation, October 16, 2012 - Octaplas Information Request Email, October 12, 2012 - Octaplas Information Request Email, October 2, 2012 - Octaplas Information Request Email, August 8, 2012 - Octaplas Information Request Email, October 18, 2012 - Octaplas Information Request Email, July 23, 2012 - Octaplas (PDF - 2.3MB)Information Request Email, June 19, 2012 - Octaplas Information Request Email, June 27, 2012 - Octaplas Information Request Email, June 7, 2012 - Octaplas Information Request Email, April 25, 2012 - Octaplas (PDF - 84KB)Record of Telephone Conversation, March 27, 2012 - Octaplas Filing Memo Reminder, February 8, 2012 am - Octaplas Filing Memo Reminder Email, February 8, 2012 am - Octaplas Filing Memo Reminder Email, February 8, 2012 pm - Octaplas Filing Memo Reminder Email, February 8, 2012 - Octaplas Filing Meeting, February 8, 2012 - Octaplas Filing Meeting, February 8, 2012 pm - Octaplas Stat Filing Memo Email, February 8, 2012 - Octaplas Filing Meeting Email, February 7, 2012 - Octaplas Filing Meeting Email, February 1, 2012 - Octaplas
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