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Center for Biologics Evaluation and Research
Results: 1843

#	Item
151	Food and Drug Administration Safety and Innovation Act (FDASIA), Section 907: Inclusion of Demographic Subgroups in Clinical Trials Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Medical device Office of Regulatory Affairs Criticism of the Food and Drug Administration Adverse Event Reporting System Food and Drug Administration Medicine Health
152	978 W H O Te c h n i c a l Add to Reading List Source URL: www.wsmi.org Language: English - Date: 2013-11-18 08:42:04 Vaccines Vaccination Pharmacology Center for Biologics Evaluation and Research Influenza World Health Organization WHO Expert Committee on Biological Standardization European Directorate for the Quality of Medicines Food and Drug Administration Medicine Health Biology
153	Plant-Derived Biologics Seminar and Public Hearing on Plant-Derived Biologics Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Vaccination Veterinary biologic Veterinary medicine Vaccine Biologic Food and Drug Administration Center for Biologics Evaluation and Research Influenza vaccine Medicine Biotechnology Health
154	Food and Drug Administration Center for Biologics Evaluation and Research 109th Meeting of the Blood Products Advisory Committee Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Clinical pharmacology Therapeutics United States Public Health Service Center for Biologics Evaluation and Research Food and Drug Administration Medicine Clinical research
155	Science at CBER: Why, How, and What? SLIDE 1 This presentation will discuss science and, in particular, the research programs at the Center for Biologics; why CBER thinks they are so integral to the regulatory mission; Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Vaccines Food and Drug Administration Vaccination Center for Biologics Evaluation and Research Biologic Whole blood Influenza vaccine Vaccinia Medicine Biotechnology Biology
156	FDA-Industry PDUFA V Reauthorization Meeting Add to Reading List Source URL: www.fda.gov Language: English Health Prescription Drug User Fee Act Center for Drug Evaluation and Research American Society of Health-System Pharmacists Pharmacy Stakeholder Center for Biologics Evaluation and Research National Health Council Food and Drug Administration Pharmaceutical sciences Medicine
157	DEPARTMENT OF HEALTH & HUMAN SERVICES Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Food and Drug Administration Clinical pharmacology Therapeutics United States Public Health Service Center for Biologics Evaluation and Research Biologic Bovine spongiform encephalopathy Feed ban Health Medicine Pharmacology
158	Guidance for Industry Electronic Submission of Lot Distribution Reports DRAFT GUIDANCE This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance b Add to Reading List Source URL: www.fda.gov Language: English Research Structured Product Labeling Center for Biologics Evaluation and Research Adverse Event Reporting System Validation Electronic Common Technical Document Federal Food Drug and Cosmetic Act Abbreviated New Drug Application Title 21 CFR Part 11 Food and Drug Administration Medicine Health
159	Guidance for Industry Providing Regulatory Submissions in Electronic Format — Add to Reading List Source URL: www.fda.gov Language: English Health ISO standards Pharmaceutical industry Pharmaceuticals policy Title 21 CFR Part 11 United States administrative law Portable Document Format Center for Biologics Evaluation and Research Arial Food and Drug Administration Medicine Pharmaceutical sciences
160	DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research Add to Reading List Source URL: www.fda.gov Language: English Drug discovery Nursing research Pharmaceutical industry Pharmacology Research Pharmaceutical sciences Science Clinical trial Design of experiments

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