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Center for Biologics Evaluation and Research
Results: 1843

#	Item
121	NOVEMBER 18TH, 2014 Inside This Issue 1 The Purple Book Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Biosimilar Biotechnology Drugs Pharmaceuticals policy Biologic Center for Biologics Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations Food and Drug Administration Medicine Health
122	Microsoft Word - Biologics Program Evaluation Final Report May 2014.docx Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2014-10-24 16:08:52 Medicine Food and Drug Administration Clinical research Pharmaceutical industry Health Products and Food Branch Center for Biologics Evaluation and Research Biologic European Medicines Agency Adverse effect Health Pharmacology Pharmaceutical sciences
123	Pediatric Advisory Committee Meeting Tuesday, December 8, 2009 Hilton, WashingtonDC/Rockville Executive Meeting Center Plaza Ballroom, 1750 Rockville Pike Rockville, Maryland, 20852 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Center for Biologics Evaluation and Research Center for Drug Evaluation and Research National Institute of Child Health and Human Development Food and Drug Administration Medicine Health
124	Small Business Guide to FDA Add to Reading List Source URL: seafood.oregonstate.edu Language: English - Date: 2013-09-03 14:05:17 Pharmaceutical sciences Title 21 CFR Part 11 Form FDA 483 Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Devices and Radiological Health Office of Regulatory Affairs Center for Biologics Evaluation and Research Good manufacturing practice Food and Drug Administration Medicine Health
125	Application Type STN CBER Received Date PDUFA Goal Date Division / Office Priority Review Add to Reading List Source URL: www.fda.gov Language: English Health Influenza vaccines Influenza Flu pandemic Pandemics Fluzone FluMist Center for Biologics Evaluation and Research Oseltamivir Vaccines Medicine Vaccination
126	FDA CBER Mini-Sentinel Program, Michael Nguyen, MD, Division of Epidemiology, Office of Biostatistics and Epidemiology Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Medicine Pharmaceutical industry Epidemiology Clinical research Clinical trial Safety monitoring Center for Biologics Evaluation and Research Health Food and Drug Administration Pharmaceutical sciences
127	[removed]Federal Register / Vol. 79, No[removed]Tuesday, December 9, [removed]Notices support findings of effectiveness and safety and helps identify appropriate Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2014-12-09 03:26:38 Blood products Transfusion medicine Hematology Food and Drug Administration Coagulation system Platelet Whole blood Blood transfusion Center for Biologics Evaluation and Research Anatomy Blood Biology
128	Rare Pediatric Disease Priority Review Vouchers, Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: November 17, 2014 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Orphan drug Priority review voucher FDA Fast Track Development Program New Drug Application Orphan Drug Act Center for Biologics Evaluation and Research Prescription Drug User Fee Act Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
129	[removed]Federal Register / Vol. 79, No[removed]Friday, July 11, [removed]Notices The Food and Drug Administration (FDA) is announcing the Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2014-07-16 16:29:05 Pharmaceutical sciences Abbreviated New Drug Application New Drug Application Generic drug Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Federal Food Drug and Cosmetic Act Structured Product Labeling Food and Drug Administration Medicine Health
130	NWX-HHS FDA (US) Moderator: Irene Aihie[removed]:30 pm CT Confirmation # [removed]Page 1 Add to Reading List Source URL: www.fda.gov Language: English Medical device Center for Devices and Radiological Health Federal Food Drug and Cosmetic Act Center for Biologics Evaluation and Research Medicine Food and Drug Administration Health

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