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Center for Biologics Evaluation and Research
Results: 1843

#	Item
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 Add to Reading List Source URL: www.fda.gov Language: English Health Food and Drug Administration Influenza vaccine FluMist Influenza Immunogenicity Center for Biologics Evaluation and Research H5N1 clinical trials Medicine Vaccination Vaccines
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 Add to Reading List Source URL: www.fda.gov Language: English Health Influenza vaccines Influenza Clinical research Flu pandemic FluMist Fluzone Clinical endpoint Center for Biologics Evaluation and Research Vaccines Vaccination Medicine
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 Add to Reading List Source URL: www.fda.gov Language: English Virus Gene therapy Biologic Biology Applied genetics Adenoviridae
114	Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology ___________________________________________________ MEMORANDUM Add to Reading List Source URL: www.fda.gov Language: English Health Meningococcal vaccine Meningococcal disease Vaccine Adverse Event Reporting System Vaccine Advisory Committee on Immunization Practices Vaccination schedule FluMist Asplenia Vaccines Vaccination Medicine
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 Add to Reading List Source URL: www.fda.gov Language: English Anatomy Health Center for Biologics Evaluation and Research Influenza Blood donation Cadaveric blood transfusion Transfusion medicine Medicine Food and Drug Administration
116	Guidance for Industry: Compliance with 21 CFR Part[removed]c)(1) – Manufacturing Arrangements Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Blood banks Clinical pharmacology Pharmacology United States Public Health Service Center for Biologics Evaluation and Research Title 21 of the Code of Federal Regulations Current Good Tissue Practices Medicine Food and Drug Administration Health
117	Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use Add to Reading List Source URL: www.fda.gov Language: English Coagulation system Acute phase proteins Blood proteins Food and Drug Administration Pharmacology Fibrin glue Thrombin Fibrin Center for Biologics Evaluation and Research Blood Anatomy Medicine
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 Add to Reading List Source URL: www.fda.gov Language: English Blood banks Orthopedic surgery Transfusion medicine Center for Biologics Evaluation and Research Autotransplantation Allotransplantation Current Good Tissue Practices Medicine Food and Drug Administration Transplantation medicine
119	Proposed Approach to Regulation of Cellular and Tissue Based Products Add to Reading List Source URL: www.fda.gov Language: English Stem cells Transplantation medicine Food and Drug Administration Pharmacology Allotransplantation Center for Biologics Evaluation and Research Cell therapy Regulatory requirement Biologic Biology Medicine Cell biology
120	Electronic Postmarket Safety Reporting Updates FDA E2B (R3) Implementation, Planning and Tools Lise R. Stevens Add to Reading List Source URL: www.fda.gov Language: English Drug safety Health Public safety Vaccine Adverse Event Reporting System Pharmacology Center for Biologics Evaluation and Research Validation SRA International Transmission Control Protocol Food and Drug Administration Medicine Safety

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