Vaccines, Blood & Biologics
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Approval History, Letters, Reviews and Related Documents - Anascorp
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Memorandum/Reviews
Summary Basis for Regulatory Action, August 2, 2011 - Anascorp (PDF - 174KB)Memorandum, July 11, 2011 - Anascorp Memorandum, July 8, 2011 - Anascorp Memorandum, July 1, 2011, Anascorp (PDF - 29KB)Memorandum, May 23, 2011 - Anascorp Memorandum, May 11, 2011 - Anascorp Clinical Review, May 6, 2011 - Anascorp (PDF - 306KB)Statistical Review and Evaluation, February 1, 2011 - Anascorp (PDF - 181KB)Official Meeting Summary, July 15, 2010 - Anascorp (PDF - 55KB)Meeting Response Memorandum, July 12, 2010 - Anascorp (PDF - 46KB)Request to Cancel Meeting Email, February 17, 2010 - Anascorp Meeting Response Memorandum, January 21, 2010 - Anascorp (PDF - 35KB)Official Meeting Summary, November 19, 2009 - Anascorp (PDF - 70KB)Meeting Minutes, November 18, 2009 - Anascorp (PDF - 50KB)Meeting Response Memorandum, November 17, 2009, Anascorp (PDF - 79KB)Meeting Response Memorandum(2), November 17, 2009, Anascorp (PDF - 87KB)Final Review Memorandum, July 13, 2009 - Anascorp (PDF - 61KB)CMC Complete Review, July 10, 2009 - Anascorp (PDF - 59KB)Bioresearch Monitoring Final Review Memo, July 7, 2009 - Anascorp Final Review Memorandum, July 8, 2009 - Anascorp (PDF - 423KB)Final Review Memorandum, June 20, 2009 - Anascorp (PDF - 32KB)MidCycle Summary Memo, April 16, 2009 - Anascorp Statistical Review and Evaluation January 22, 2009 - Anascorp (PDF - 63KB)Midcycle Review Memorandum, April 16, 2009 -Anascorp (PDF - 34KB)Mid-Cycle Review Memorandum(2), April 16, 2009 - Anascorp Mid-Cycle Review Memorandum, April 12, 2009 - Anascorp (PDF - 368KB)Mid-Cycle Memorandum, April 14, 2009 - Anascorp (PDF - 68KB)Request for Priority Review Memorandum, February 11,2009 - Anascorp Clinical Review, January 22, 2009 - Anascorp (PDF - 412KB)Statistical Review and Evaluation (MID-Cycle Review Memo), January 22, 2009 - Anascorp (PDF - 63KB)Final Review Memorandum, November 11, 2008 - Anascorp (PDF - 56KB)Summary of Meeting Memorandum - Anascorp Complete Response Letter Recommendation - Anascorp (PDF - 125KB)Final CMC Review (PDF - 48KB)- Review of CR Letter Response (PDF - 145KB)
Proprietary Name Review Acceptance Memorandum - Anascorp Clinical Pharmacology Review-Anascorp (PDF - 92KB)Final Memo - Anascorp (PDF - 57KB)Final Memorandum - Anascorp (PDF - 60KB)Veterinarian Consult Review - Anascorp (PDF - 32KB)Appendix B - Anascorp (PDF - 26KB)Instituto Biocón’s Concepts of Process Validation (PV) for Anascorp (PDF - 69KB)Official Meeting Summary Coverletter Resubmission Confirmation Letter - Anascorp Review of Amendment-Anascorp (PDF - 19KB)Final Review - Anascorp (PDF - 20KB)Final Review Memorandum-Anascorp (PDF - 38KB)Revised CR Letter - Anascorp (PDF - 98KB)
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Correspondence
Excursion Discussion Email, August 2, 2011 - Anascorp Record of Telephone Conversation(2), August 2, 2011 - Anascorp Record of Telephone Conversation, August 2, 2011, Anascorp Information Request, August 1, 2011 - Anascorp Specifications Question Email, July 19, 2011 - Anascorp Anascorp PI revisions Email, July 20, 2011 - Anascorp Tcon with RDT re: STN 125335/0 Email, July 19, 2011 - Anascorp Draft Note Email, July 14, 2011 - Anascorp Questions Email, July 13, 2011 - Anascorp Carton Container Email, July 12, 2011 - Anascorp Lot Release Protocol Revisions Email, July 8, 2011 - Anascorp Pharmacovigilence STN 125355/0 Anascorp Email, July 06, 2011 - Anascorp - Information Request Email, July 6, 2011 - Anascorp
Information Request Email, July 5, 2011 - Anascorp Information Request Email, June 29, 2011 - Anascorp Information Request Email, April 11, 2011 - Anascorp Information Request Email, March 4, 2011 - Anascorp Information Request Email, February 16, 2011 - Anascorp Information Request Email, February 14, 2011 - Anascorp Information Request Email, February 9, 2011 - Anascorp Regarding Rev090705fnl document Email, July 08, 2009 - Anascorp Horse Facility Registration Email, April 16, 2009 Rescheduled Midcycle Meeting Email, April 15, 2009, Anascorp Information Request , April 14, 2009- Anascorp (PDF - 56KB)Record of Telephone Conversation, November 17, 2010 - Anascorp Response Questions for Teleconference Email, July 12, 2010 - Anascorp Record of Telephone Conversation, June 3, 2010 - Anascorp Response to Information Request Email, February 17, 2010, Anascorp Record of Telephone Conversation, January 10, 2010 - Anascorp FAX of Meeting Responses Email, November 17, 2009 Comments Email, July 10, 2009 - Anascorp Information Request, June 10, 2009 - Anascorp (PDF - 33KB)Name Review Email, April 30, 2009 - Anascorp (PDF - 26KB)Information Request - April 17, 2009 - Anascorp (PDF - 25KB)Information Request(2), April 21, 2009- Anascorp (PDF - 44KB)Information Request, April 21, 2009- Anascorp (PDF - 25KB)Record of Television Conversation, April 17, 2009 - Anascorp Information Request - March 26, 2009 - Anascorp (PDF - 25KB)Information Request, March 25, 2009 - Anascorp (PDF - 57KB)Information Request, March 12, 2009 - Anascorp (PDF - 30KB)Information Request, March 11, 2009 - Anascorp (PDF - 25KB)Record of Telephone Conversation, March 5, 2009 - Anascorp Questions Email, March 5, 2009 - Anascorp Record of Telephone Conversation, March 2, 2009 - Anascorp Information Request, February 6, 2009 - Anascorp (PDF - 94KB)Information Request, February 26, 2009 - Anascorp (PDF - 30KB)Information Request(2), February 6, 2009 - Anascorp (PDF - 28KB)- Information Request, February 24, 2009-Anascorp (PDF - 25KB)
Record to Telephone Conversation - January 29, 2009 - Anascorp RDT Protein Specification Change Email, July 15, 2011 - Anascorp
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