Vaccines, Blood & Biologics
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Approval History, Letters, Review, and Related Documents - EVARREST
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Memorandum Reviews
Non-clinical Labeling for Revised Summary Basis for Regulatory Action Memo - EVARREST (PDF - 29KB)Non-clinical Labeling for Package Insert and Summary Basis for Regulatory Action Memo - EVARREST (PDF - 27KB)Non-Clinical Filing Memo - EVARREST (PDF - 22KB)Complete Response 2 letter, revised November 29, 2012 - Evarrest (PDF - 3.7MB)BPAC Waiver Memo - EVARREST (PDF - 23KB)Review Memo, September 29, 2012 - EVARREST (PDF - 28KB)Final Review of CMC Information Memo, September 26, 2012 - EVARREST (PDF - 108KB)Response to CR Memo, September 11, 2012 - EVARREST (PDF - 533KB)Internal Meeting Memo, September 7, 2012 - EVARREST (PDF - 389KB)Telecon Record with CDRH Memo, September 4, 2012 - EVARREST (PDF - 26KB)Final Review Memo, August 27, 2012 - EVARREST (PDF - 65KB)- Filing of Midcycle for Clinical Hold Response Memo - EVARREST (PDF - 29KB)
- Resubmission Mid-Cycle Meeting Minutes Memo, June 22, 2012 - EVARREST (PDF - 36KB)
- Second Committee Meeting for Amendment to original BLA Memo, May 17, 2012 - EVARREST (PDF - 37KB)
- First Committee Meeting for Amendment to original BLA Memo, April 19, 2012 - EVARREST (PDF - 29KB)
Review Memorandum for Original BLA - EVARREST, August 30, 2011 (PDF - 55KB)Clinical First Round Memorandum - EVARREST, August 8, 2011 (PDF - 1.1MB)Final Review Memorandum - EVARREST, August 1, 2011 (PDF - 142KB)Committee Meeting Minutes Memorandum - EVARREST, July 11, 2011 (PDF - 65KB)Mid-Cycle Review Memorandum - EVARREST, June 6, 2011 (PDF - 124KB)Information Request Memorandum - EVARREST, May 31, 2011 Information Request Memo - EVARREST, May 5, 2011 Mid-Cycle Meeting Minutes Memo - EVARREST, April 20, 2011 (PDF - 89KB)Bioresearch Monitoring Midcycle Review Memo, April 19, 2011 - EVARREST Filing Meet Minutes - EVARREST, January 3, 2011 First Committee Meeting MInutes - EVARREST, December 7, 2010 - Statistical Review and Evaluation, November 4, 2010 - EVARREST (PDF - 1.6MB)
Filing Memorandum for Original BLA for Fibrin Pad - EVARREST (PDF - 69KB)Information Request Memorandum - EVARREST Memorandum - EVARREST Deficiencies Filiing Memorandum - EVARREST Proprietary Name Memorandum - EVARREST Midcycle Review Memorandum - EVARREST (PDF - 102KB)Mid Cycle Review Memo - EVARREST Mid-Cylcle Review of CMC Information Memorandum - EVARREST (PDF - 162KB)Review Memo BLA - EVARREST (PDF - 187KB)Review of a Comparability Protocol Memorandum - EVARREST (PDF - 67KB)Final Fililing Memorandum- EVARREST (PDF - 99KB)Final Review of CMC Information Memo - EVARREST (PDF - 223KB)Summary Review of the Original BLA - EVARREST (PDF - 134KB)Complete Review Memo - EVARREST (PDF - 84KB)
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Correspondence
Acknowledgement Letter - EVARREST (PDF - 21KB)Reducing Respone Time Letter - Evarrest Information Request, November 29, 2012 - Evarrest (PDF - 59KB)Record of Telephone Conversation, November 28, 2012 - Evarrest Record of Telephone Conversation, November 27, 2012 - EVARREST Record of Telephone Conversation, November 26, 2012 - EVARREST Information Request, November 16, 2012 - Evarrest (PDF - 40KB)Record of Telephone Conversation, October 26, 2012 - EVARREST Reducing Response Time Letter - EVARREST (PDF - 18KB)- Record of Telephone Conversation, October 5, 2012 - EVARREST
Email CMC Final Review memo, September 28, 2012 - EVARREST Resubmission Acknowledgement Email, September 26, 2012 - EVARREST Package Insert Points of Clarification Email, September 25, 2012 - EVARREST (PDF - 17KB)FDAAA Section 916 Officer/Employee List for STN 125392/0 Email, September 24, 2012 - EVARREST (PDF - 68KB)Record of Telephone Conversation, September 24, 2012 - EVARREST Record of Telephone Conversation, September 21, 2012 - EVARREST - Ethicon/Omrix's EVARREST Update Email, September 19, 2012
Record of Telephone Conversation, September 19, 2012 - EVARREST PeRC Outcome Email, September 19, 2012 - EVARREST - Information Request Email, September 14, 2012 - EVARREST
Package Insert Revisions Email, September 11, 2012 - EVARREST (PDF - 19KB)Report of Telephone Conversation, September 7, 2012 - EVARREST Record of Telephone Conversation, August 23, 2012 PM- EVARREST Record of Telephone Conversation, August 23, 2012 - EVARREST Record of Telephone Conversation, August 22, 2012 - EVARREST - Teleconference Email, August 20, 2012 - EVARRAST
Information Request Email, August 8, 2012 - EVARREST (PDF - 23KB)Record of Telephone Conversation, August 2, 2012 - EVARREST - FDA Teleconference Email, August 2, 2012 - EVARREST
- Review Email, July 26, 2012 - EVARREST
- Information Request Email, July 16, 2012 - EVARREST
Omrix Fibrin Pad Follow Up Email, July 10, 2012 - EVARREST Record of Telephone Conversation, June 27, 2012 - EVARREST (PDF - 26KB)- Resubmission Review Email, June 13, 2012 - EVARREST
- Record of Telephone Conversation, May 24, 2012 - EVARREST
Resubmission Acknowledgement - EVARREST, April 11, 2012 (PDF - 138KB)Record of Telephone Conversation - EVARREST, April 11, 2012 Omrix Email - EVARREST, August 2, 2011 Report of Telephone Conversation - EVARREST, August 2, 2011 Filing Memo Email, January 11, 2011 - EVARREST (PDF - 16KB)Report of Telephone Conversation - EVARREST, June 7, 2011 Information Request - EVARREST, January 5, 2011 Filing Letter - EVARREST Resubmission Acknowledgment Letter - EVARREST
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