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Center for Drug Evaluation and Research
Results: 4314

#	Item
211	(System Info[removed]SMITH MICHAEL[removed]:32:55 SMITHM) RECORD OF TELEPHONE CONVERSATION Submission Type: BLA Submission ID: [removed] Add to Reading List Source URL: www.fda.gov Language: English Biotechnology Pharmacology Center for Biologics Evaluation and Research Influenza FDA Fast Track Development Program Pfizer Wyeth Prescription Drug User Fee Act Jim Medicine Food and Drug Administration Health
212	[removed]Federal Register / Vol. 79, No[removed]Tuesday, December 23, [removed]Notices veterinary and human drug products and human biological drug products. FDA estimates that approximately two Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2015-01-07 11:27:32 Safety Center for Food Safety and Applied Nutrition Center for Biologics Evaluation and Research Food safety Office of Regulatory Affairs Title 21 of the Code of Federal Regulations Food and Drug Administration Health Medicine
213	(System Info[removed]SMITH MICHAEL[removed]:48:05 SMITHM) RECORD OF TELEPHONE CONVERSATION Submission Type: BLA Submission ID: [removed] Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Food and Drug Administration Pharmaceutical industry Clinical Data Management Electronic Common Technical Document Validation Center for Biologics Evaluation and Research Biologic Vaccine Research Medicine Clinical research
214	MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Center for Biologics Evaluation and Research Office of Vaccines Research and Review Add to Reading List Source URL: www.fda.gov Language: English Biology Health HPV vaccine Human papillomavirus Gardasil Papillomaviridae Assay Clinical Laboratory Improvement Amendments Cervarix Papillomavirus Medicine Vaccines
215	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
216	(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
217	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
218	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
219	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
220	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

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