Vaccines, Blood & Biologics
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Approval History, Letters, Reviews, and Related Documents - Cervarix
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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.
Clinical Review Memo - Cervarix, October 15, 2009 (PDF - 16.9MB)Postmarketing Requirement (PMR) Review Memo - Cervarix BLA Pharmacovigilance Plan Review - Cervarix Review of Container and Packaging Labeling - Cervarix Categorical Exclusion - Cervarix Proposed Logo Review Memo - Cervarix Statistical Review - Cervarix Revised Draft Product Labeling Review Memo - Cervarix Re-evaluation of Proposed Proprietary Name Review Memo - Cervarix Letter - Cervarix Summary of Bioresearch Monitoring Inspection - Cervarix, September 5, 2008 Proposals for Class 2 Resubmission Memo - Cervarix, September 3, 2008 Review Memo for the Pre-License Inspection Relative Potency of Cervarix MPL Review for the FDA - Cervarix, April 18, 2008 August 21 Pharmacovigilance Comments-Cervarix, October 19, 2007 Postmarketing Safety Data - Cervarix, October 9, 2007 Response to Sep 26th Request; Unblinded Data - Cervarix, September 27, 2007 Clinical Review of Amendment - Cervarix, August 15, 2007 Meta Analysis of Adverse Events - Cervarix, August 12, 2007 Memorandum - Cervarix, August 10, 2007 (PDF - 341KB)Unblinded Tables and Protocol HPY-009 Subjects - Cervarix, July 6, 2007 (PDF - 53KB)BiMo GSK Request Email- Cervarix, May 22, 2007 BiMo Clarification - Cervarix, May 22, 2007 Acknowledgement Letter - Cervarix, May 24, 2007 BLA125259 Memo - Cervarix, May 3, 2007 (PDF - 55KB)BiMo Request-Clarification - Cervarix, May 16, 21, 2007 Information in Summary of Clinical Efficacy-Cervarix, May 7, 2007 Record of Telephone Conversation - Cervarix, April 30, 2007 Bioresearch Monitoring Comment-Cervarix, April 25, 2007 First Committee Meeting - Cervarix, April 19, 2007 Filing Letter - Cervarix, April 9, 2007 Toxicology Review Memo - Cervarix, May 30, 2008 (PDF - 3.7MB)Final MPL CMC Review - Cervarix, October 13, 2009 (PDF - 538KB)Product Review and Approval Recommendation - Cervarix, September 14, 2009 (PDF - 488KB)Comments Regarding Assay Validation - Cervarix, September 7, 2007 (PDF - 55KB)Statistical Review and Evaluation - Resubmission - Cervarix, November 30, 2009 (PDF - 1.2MB)Preclinical Developmental Toxicity Study Reports - Cervarix, June 9, 2009 (PDF - 1.1MB)Adverse Events and MPL Memo - Cervarix, July10, 2007 (PDF - 43KB)Review Memo Cervical Cancer Vaccine - Cervarix (PDF - 172KB)Review of Toxicological Information- Cervarix (PDF - 199KB)Mid-Cycle Review Meeting Summary on CMC - Cervarix (PDF - 169KB)Discussion of Complete Response Letter Safety Items - Cervarix, January 16, 2008 (PDF - 321KB)Request for Comment on Proposals - Cervarix (PDF - 101KB)Response to the Review Teams Comments Memo - Cervarix (PDF - 433KB)Response to the review team’s comments on proposals for Class 2 Resubmission - Cervarix, November 22, 2009 (PDF - 324KB)Signatory Authority Decisional Memorandum to the File - Cervarix, October 15, 2009 (PDF - 169KB)Request for Patient Source Documents - Cervarix, July 23, 2007 (PDF - 39KB)Pregnancy Outcomes and MPL AEs - Cervarix, July 26, 2007 (PDF - 50KB)Developmental Toxicity Studies - Cervarix, August, 31, 2007 (PDF - 36KB)Unblinded Narratives HPV-009 - Cervarix, September 20, 2007 (PDF - 29KB)Request for CMC information - Cervarix, October 1, 2007 (PDF - 57KB)Partal Resonse to Email of Sep 20, 2007 - Cervarix, October 23, 2007 (PDF - 41KB)
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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 - Cervarix, October 20, 2009 Record of Telephone Conversation - Cervarix, October 14, 2009 Cervarix Final Label Email - Cervarix, October 14, 2009 Record of Telephone Conversation - Cervarix, October 9, 2009 Record of Telephone Conversation - Cervarix, October 8, 2009 Record of Telephone Conversation - Cervarix, October 7, 2009 PM Record of Telephone Conversation - Cervarix, October 7, 2009 with Attachment Record of Telephone Conversation - Cervarix, October 7, 2009 Record of Telephone Conversation - Cervarix, October 6, 2009 Record of Telephone Conversation - Cervarix, October 2, 2009 with Attachments Record of Telephone Conversation - Cervarix, October 2, 2009 Record of Telephone Conversation - Cervarix, September 30, 2009 Record of Telephone Conversation - Cervarix, Sept 30, 2009 Record of Telephone Conversation - Cervarix, September 22, 2009 Record of Telephone Conversation - Cervarix, September 21, 2009 (PDF - 190KB)Record of Telephone Conversation - Cervarix, September 18, 2009 Record of Telephone Conversation - Cervarix, Sept. 18, 2009 Record of Telephone Conversation - Cervarix, September 16, 2009 Record of Telephone Conversation - Cervarix, Sept. 16, 2009 Record of Telephone Conversation - Cervarix, September 15, 2009 Record of Telephone Conversation - Cervarix, Sept. 2, 2009 Record of Telephone Conversation - Cervarix, Sept. 2, 2009, AM Record of Telephone Conversation - Cervarix, Sept. 1, 2009 Record of Telephone Conversation - Cervarix, September 1, 2009 Record of Telephone Conversation - Cervarix, August 28, 2009 Record of Telephone Conversation - Cervarix, August 28, 2009 PM Record of Telephone Conversation - Cervarix, August 27, 2009 Record of Telephone Conversation - Cervarix, August 26, 2009 Record of Telephone Conversation - Cervarix, August 25, 2009 Record of Telephone Conversation - Cervarix, August 11, 2009 Record of Telephone Conversation - Cervarix, August 5, 2009 Record of Telephone Conversation - Cervarix, July 30, 2009 AM Record of Telephone Conversation - Cervarix, Jul. 30, 2009 Record of Telephone Conversation - Cervarix, July 26, 2009 PM Record of Telephone Conversation - Cervarix, July 26, 2009 Record of Telephone Conversation - Cervarix, July 14, 2009 Record of Telephone Conversation - Cervarix, July 10, 2009 Record of Telephone Conversation - Cervarix, July 1, 2009 Record of Telephone Conversation - Cervarix, June 29, 2009 Record of Telephone Conversation - Cervarix, June 29, 2009 PM Record of Telephone Conversation - Cervarix, June 22, 2009 AM Record of Telephone Conversation - Cervarix, June 22, 2009 Record of Telephone Conversation - Cervarix, June 19, 2009 Mid-Cycle Review Meeting Summary - Cervarix, June 17, 2009 Record of Telephone Conversation - Cervarix, April 1, 2009 Record of Telephone Conversation - Cervarix, May 4, 2009 Record of Telephone Conversation - Cervarix, November 5, 2008 Record of Telephone Conversation - Cervarix, October 24, 2008 Record of Telephone Conversation - Cervarix, September 10, 2008 Record of Telephone Conversation - Cervarix, August 6, 2008 Record of Telephone Conversation - Cervarix, June 19, 2008 Record of Telephone Conversation - Cervarix, April 14, 2008 Record of Telephone Conversation - Cervarix, March 19, 2008 Record of Telephone Conversation - Cervarix, March 18, 2008 Record of Conversation - Cervarix, February 26, 2008 Record of Telephone Conversation - Cervarix, December 20, 2007 Telecon Notes - Cervarix, December 14, 2007 Record of Telephone Conversation - Cervarix, December 11, 2007 Record of Telephone Conversation - Cervarix, December 7, 2007 Telecon - GSK Cervarix, December 06, 2007 Questions on Clinical Assays - Cervarix, November 2, 2007 Record of Telephone Conversation - Cervarix, October 24, 2007 Response to FDA Question of October 12, 2007 - Cervarix, October 26, 2007 Partial Response to Email of Oct 15, 2007 - Cervarix, October 23, 2007 Telecon - Cervarix, October 18, 2007 Narratives Request - Cervarix, October 15, 2007 Source Documents and Narratives - Cervarix, October 15, 2007 Cervarix - Question RE Oct 11 submission, October 12, 2007 Record of Telephone Conversation - Cervarix, October 5, 2007 Response to FDA Request of Oct 2, 2007- Cervavix, October 4, 2007 Cervarix - Request, October 4, 2007 Homogeneity Testing - Cervarix, October 3, 2007 HPV-009 – Treatment Allocations- Cervarix, October 2, 2007 Request for post-marketing safety data for Cervarix, October 2, 2007 HPV-010 Subject Treatment Allocation - Cervarix, September 26, 2007 August 29 Clinical Request - Cervarix, September 20, 2007 Request for Clinical Narratives - Cervarix, September 6, 2007 Meta-Analysis of Adverse Events- Cervarix, September 4, 2007 Reference Standard - Cervarix, August 31, 2007 Clinical Narratives Request - Cervarix, August 29, 2007 Telecon Summary, Information Request - Cervarix, August 29, 2007 Stat Comments Response, August 12, 2007- Cervarix, August 22, 2007 Record of Telephone Conversation - Cervarix, August 21, 2007 Stat Comments Response, August 12, 2007 - Cervarix, August 20, 2007 Telecon - GSK Cervarix, August 14, 2007 Record of Telephone Conversation-Cervarix, August 9, 2007 Record of Telephone Conversation - Cervarix, August 9, 2007 Clinical Narratives Request - Cervarix, August 8, 2007 Submission of Report to BLA - Cervarix, August 2, 2007 Cervarix - July 26 Clinical Comments - August 08, 2007 Clinical Narrative Request - Cervarix, August 3, 2007 Treatment Assignments – HPV-009- Cervarix, August 1, 2007 Unblinded Tables - Cervarix, August 1, 2007 Record of Telephone Conversation - Cervarix, July 29, 2009 (PDF - 38KB)Mid-Cycle Review Meeting Summary - Cervarix, July 24, 2007 PIDs and Associated Study Numbers-Cervarix, July 20, 2007 UNSOL_AE Dataset Narratives - Cervarix, July 18, 2007 CBER’s July 18 Clinical Request RE: AE Variables - Cervarix, July 19, 2007 Record of Telephone Conversation - Cervarix, July 18, 2007 Memo of Telecon - Cervarix, June 20, 2007 Record of Telephone Conversation - Cervarix, June 7, 2007 Clinical Request - Cervarix, June 5, 2007 Record of Telephone Conversation - Cervarix, June 1, 2007 Filing Memo - Cervarix, May 18, 2007 Arthritis, Fibromyalgia, Alopecia Clinical Narratives BiMo Clarification Email - Cervarix, May 23, 2007 Record of Telephone Conversation - Cervarix, May 4, 2007 Memo of Telecon - Cervarix, June 14, 2007 (PDF - 53KB)Memo of Telecon - Cervarix, June 18, 2007 (PDF - 58KB)Request for CMC Information - Cervarix, August 7, 2007 (PDF - 57KB)
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