Vaccines, Blood & Biologics
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Approval History, Letters, Reviews and Related Documents - Adenovirus
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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.
Final Clinical Review, March 15, 2011- Adenovirus (PDF - 534KB)DPQ Review Memo, January 25, 2011 - Adenovirus (PDF - 85KB)Pharmacovigilance Plan Review, January 20, 1011 (PDF - 107KB)- Filing Letter - Adenovirus
- Updated Labeling Review Memo, January 10, 2011 - Adenovirus (PDF - 25KB)
Mid-Cycle Meeting Summary, December 8, 2010 - Adenovirus (PDF - 30KB)Summary of Bioresearch Monitoring Inspections, April 20, 2010 - Adenovirus (PDF - 11KB)Product Name Comment Review Memo, June 26, 2009 - Adenovirus CMC Review, May 23, 2009 - Adenovirus (PDF - 113KB)Appendix to CMC Review - Adenovirus (PDF - 201KB)Labeling Review Memo, May 12, 2009 - Adenovirus (PDF - 34KB)Unacceptable Proposed Name, May 1, 2009 - Adenovirus Statistical Review and Evaluation, April 21, 2009 - Adenovirus (PDF - 118KB)Proprietary Name Withdrawal, March 16, 2009 - Adenovirus Mid-Cycle Committee Meeting, February 27, 2009 - Adenovirus (PDF - 34KB)Filing Meeting Summary, November 7, 2008 - Adenovirus (PDF - 35KB)Toxicology Review - Adenovirus Reproductive Toxicology Studies, Amendment No. 9, March, 18, 2005 - Adenovirus Review of the original BLA Memo - Adenovirus (PDF - 252KB)Information Request Letter - Adenovirus Complete Review Letter - Adenovirus
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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.
Record of Telephone Conversation, March 4, 2011 - Adenovirus Record of Telephone Conversation, March 1, 2011 - Adenovirus Record of Telephone Conversation, February 26, 2011 - Adenovirus Record of Telephone Conversation, February 25, 2011 - Adenovirus Record of Telephone Conversation, February 22, 2011 - Adenovirus Email - Compliance Check, February 17, 2011 - Adenovirus Record of Telephone Conversation, February 15, 2011 - Adenovirus Record of Telephone Conversation, February 7, 2011 - Adenovirus Record of Telephone Conversation, Jan. 26, 2011 - Adenovirus Record of Telephone Con., January 26, 2011 - Adenovirus Record of Telephone Conversation, January 26, 2011 - Adenovirus Record of Telephone Conversation, January 25, 2011 - Adenovirus Email, December 06, 2010 - Adenovirus Record of Telephone Conversation, December 6, 2010 - Adenovirus Record of Telephone Conversation, December 3, 2010 - Adenovirus Record of Telephone Conversation, October 22, 2010 - Adenovirus Record of Telephone Conversation, August 16, 2010 - Adenovirus Record of Telephone Conversation, May 27, 2009 - Adenovirus Telecon - Inspection and PMC Surveillance, May 19, 2009 - Adenovirus Request for Additional Information Email, May 15, 2009 - Adenovirus - Record of Telephone Conversation, May 8, 2009 - Adenovirus
Email - Stability Data, May 1, 2009 - Adenovirus Email - Post Marketing Surveillance, April 15, 2009 -Adenovirus Email - Testing Information Request, March 12, 2009 - Adenovirus (PDF - 34KB)Email - Lyophilization Scale Up, March 4, 2009 - Adenovirus Email - Major Amendment, February 26, 2009 - Adenovirus Email - Proprietary Name Withdrawal, February 17, 2009 - Adenovirus Record of Telephone Conversation, January 13, 2009 - Adenovirus Record of Telephone Conversation, January 27, 2009 - Adenovirus Vaccine TeleCon, PNR Review, December 15, 2008 - Adenovirus Class 2 Response - Adenovirus Fax - Response to Duramed’s IND (b)(4), Amendment #9, May 3, 2005 - Adenovirus
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