111![Summary Basis for Regulatory Action Date: October 28, 2014 From: Timothy A. Fritz, PhD, Review Committee Chair BLA/ STN#: [removed]Applicant Name: Protein Sciences Corporation Date of Submission: October 21, 2013 Summary Basis for Regulatory Action Date: October 28, 2014 From: Timothy A. Fritz, PhD, Review Committee Chair BLA/ STN#: [removed]Applicant Name: Protein Sciences Corporation Date of Submission: October 21, 2013](https://www.pdfsearch.io/img/6d21ab0b837e65b9390ee533c0d0720a.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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112![Summary Basis for Regulatory Action Date: October 30, 2014 From: CDR Edward W. Wolfgang, MSA, Chair of the Review Committee BLA/ STN: [removed]Applicant Name: Sanofi Pasteur Inc. Date of Submission: December 30, 2013 Summary Basis for Regulatory Action Date: October 30, 2014 From: CDR Edward W. Wolfgang, MSA, Chair of the Review Committee BLA/ STN: [removed]Applicant Name: Sanofi Pasteur Inc. Date of Submission: December 30, 2013](https://www.pdfsearch.io/img/0f2ee9242d3410fbdadead3a7616779e.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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113![FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE Meeting #61, November 6, 2014 CITED PUBLICATIONS Couch et al., The minimal infectious dose FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE Meeting #61, November 6, 2014 CITED PUBLICATIONS Couch et al., The minimal infectious dose](https://www.pdfsearch.io/img/34815b08be0ba621ed3f34b08d066cdd.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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114![Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology ___________________________________________________ MEMORANDUM Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology ___________________________________________________ MEMORANDUM](https://www.pdfsearch.io/img/dad255c2fa91ccc2e5213035f83640b0.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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115![Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Prod Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Prod](https://www.pdfsearch.io/img/24289337f65ac6c2e14a3c24191a557b.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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116![Guidance for Industry: Compliance with 21 CFR Part[removed]c)(1) – Manufacturing Arrangements Guidance for Industry: Compliance with 21 CFR Part[removed]c)(1) – Manufacturing Arrangements](https://www.pdfsearch.io/img/be926d4fa1e3122b47ecc54a9633201e.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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117![Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use](https://www.pdfsearch.io/img/41fbc0979327cb0b4f9b4e991a411c38.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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118![Same Surgical Procedure Exception under 21 CFR[removed]b): Questions and Answers Regarding the Scope of the Exception Draft Guidance for Industry DRAFT GUIDANCE Same Surgical Procedure Exception under 21 CFR[removed]b): Questions and Answers Regarding the Scope of the Exception Draft Guidance for Industry DRAFT GUIDANCE](https://www.pdfsearch.io/img/c39ca8c16f7e4cafe6f7bb8ed7b7f50b.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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119![Proposed Approach to Regulation of Cellular and Tissue Based Products Proposed Approach to Regulation of Cellular and Tissue Based Products](https://www.pdfsearch.io/img/e7d5433934e3ffb7e9a79cadce9d4f8a.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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120![Electronic Postmarket Safety Reporting Updates FDA E2B (R3) Implementation, Planning and Tools Lise R. Stevens Electronic Postmarket Safety Reporting Updates FDA E2B (R3) Implementation, Planning and Tools Lise R. Stevens](https://www.pdfsearch.io/img/f110a0e2e54cdce210df228ab3783810.jpg) | Add to Reading ListSource URL: www.fda.govLanguage: English |
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