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Results: 1831

#	Item
731	Date Manufacturer Product Indication Biologic or Drug Reason/Comments[removed] JNJ Paliperidone Palmitate Schizophrenia Drug N/A[removed] BioDelivery Sciences Bema Fentanyl, which will be marketed in the US as Onsolis Add to Reading List Source URL: www.eyeonfda.com Language: English - Date: 2010-11-01 16:40:13 Oritavancin Medicine Biology Targanta Therapeutics Corporation Pharmacology Food and Drug Administration Methicillin-resistant Staphylococcus aureus New Drug Application Skin and skin structure infection Eli Lilly and Company Glycopeptide antibiotics Pharmaceutical sciences
732	Center for Biologics Evaluation and Research Overview of the Regulatory Approaches to Biological Products Peter Marks, M.D., Ph.D. Deputy Director Add to Reading List Source URL: www.fda.gov. Language: English Pharmacology Vaccination Center for Biologics Evaluation and Research Influenza Biologic Food and Drug Administration Vaccine Veterinary biologic Medicine Biotechnology Health
733	Curriculum Vitae: Andreas Reimold Add to Reading List Source URL: www.fda.gov Language: English Laurie Glimcher Rheumatoid arthritis Arthritis Foundation Arthritis Rheumatism Autoimmunity Biologic Medicine Health Rheumatology
734	FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH MEMORANDUM Date: Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Validity Blood products Center for Biologics Evaluation and Research Endotoxin Validation Methamphetamine Biologic Plasmapheresis Medicine Quality Biology
735	Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmaceuticals policy Pharmacology Pharmaceutical industry Center for Biologics Evaluation and Research Biologic License Application Biologic Good manufacturing practice Regulatory requirement Food and Drug Administration Medicine Health
736	Microsoft Word - FDA_AMCPComments_PharmacologyStudiestoSuppportBiosimilarity_August2014 Add to Reading List Source URL: www.amcp.org Language: English - Date: 2014-08-12 11:24:23 Biosimilar Biotechnology Drugs Food and Drug Administration Biologic Clinical pharmacy Pharmacy Pharmaceutical sciences Pharmacology Clinical research
737	Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2014 This is the list of guidance topics CBER is considering for development during Calendar Year[removed]The list includes topics that c Add to Reading List Source URL: www.fda.gov. Language: English Stem cells Pharmacology Food and Drug Administration Blood banks Childbirth Center for Biologics Evaluation and Research Cord blood Biologic Gene therapy Biology Medicine Biotechnology
738	PUBLIC WORKSHOP: RISK MITIGATION STRATEGIES TO ADDRESS PROCOAGULANT ACTIVITY IN IMMUNE GLOBULIN PRODUCTS Add to Reading List Source URL: www.fda.gov Language: English Coagulation system Pharmacology Food and Drug Administration Blood products Glycoproteins Intravenous immunoglobulin Center for Biologics Evaluation and Research Biologic Deep vein thrombosis Biology Medicine Blood
739	MEMORANDUM 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 Biology Vaccines Vaccination Adenoviridae Adenovirus vaccine Biologic Food and Drug Administration Center for Biologics Evaluation and Research Privacy Biotechnology Medicine Pharmacology
740	CDISC Activities at the Center for Biologics Evaluation and Research (CBER) Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmacology Clinical Data Management Clinical Data Interchange Standards Consortium Center for Biologics Evaluation and Research SDTM Biologic Gap analysis Clinical research Research Food and Drug Administration

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