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Center for Biologics Evaluation and Research
Results: 1843

#	Item
101	Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research From: Add to Reading List Source URL: www.fda.gov Language: English Biology Meningococcal vaccine Meningococcal disease Neisseria Gardasil Meningitis Vaccination Influenza NmVac4-A/C/Y/W-135 Vaccines Medicine Health
102	(System Info[removed]SMITH MICHAEL[removed]:44:31 SMITHM) RECORD OF TELEPHONE CONVERSATION Submission Type: BLA Submission ID: [removed] Add to Reading List Source URL: www.fda.gov Language: English Clinical research Food and Drug Administration Center for Biologics Evaluation and Research Influenza Wyeth Biologic Vaccine Email Biotechnology Medicine Pharmacology
103	DEPARTMENT OF HEALTH & HUMAN SERVICES FDA, Center for Biologics Evaluation and Research MEMORANDUM Date: 27 October 2014 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Madison New Jersey Pfizer Wyeth Neisseria Vaccine Pharmaceutical drug Food and Drug Administration Meningococcal disease Pharmacology Medicine Pharmaceutical sciences
104	Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry Add to Reading List Source URL: www.fda.gov Language: English Center for Biologics Evaluation and Research Investigational New Drug Federal Food Drug and Cosmetic Act Abbreviated New Drug Application New Drug Application Medical device Electronic Common Technical Document Title 21 CFR Part 11 Structured Product Labeling Medicine Food and Drug Administration Health
105	Memorandum Food and Drug Administration Center for Biologics Evaluation and Research Office of Compliance and Biologics Quality Division of Manufacturing and Product Quality To: Add to Reading List Source URL: www.fda.gov Language: English Quality Validation Validity HTML element Pfizer Error Bookmark Computing Science Measurement Web browsers Pharmaceutical industry
106	RECORD OF TELEPHONE CONVERSATION Submission Type: BLA Submission ID: [removed]Office: OVRR Add to Reading List Source URL: www.fda.gov Language: English Vaccines Vaccination Food and Drug Administration Microbiology Virology Wyeth Center for Biologics Evaluation and Research Medicine Health Biology
107	PDUFA V Annual IT Assessment FY2014 Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Investigational New Drug Electronic Common Technical Document New Drug Application Center for Biologics Evaluation and Research Adverse Event Reporting System Common Technical Document Food and Drug Administration Medicine Research
108	[removed]Federal Register / Vol. 63, No[removed]Thursday, May 14, [removed]Proposed Rules failure of the hydraulic extension system, accomplish the following: Add to Reading List Source URL: www.fda.gov Language: English Stem cells Cell biology Biotechnology Developmental biology Current Good Tissue Practices Allotransplantation Cell therapy Center for Biologics Evaluation and Research Cord blood Biology Medicine Food and Drug Administration
109	Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Stem cells Transplantation medicine Blood banks Allotransplantation Immunology Center for Biologics Evaluation and Research Tissue Bone Biology Medicine Anatomy
110	Summary Basis for Regulatory Action Date: October 29, 2014 From: Drusilla L Burns, Ph.D., Chair of the Review Committee BLA/ STN#: [removed]Applicant Name: Wyeth Pharmaceuticals Inc. Date of Submission: June 16, 2014 Add to Reading List Source URL: www.fda.gov Language: English Biology Microbiology Neisseria Proteobacteria Center for Biologics Evaluation and Research Biologic NmVac4-A/C/Y/W-135 Meningococcal vaccine Vaccines Biotechnology Medicine

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