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#	Item
931	Within Our Reach Grant Recipients Fifth-round Grant Recipients Clinical Trial Planning Grants Cynthia Aranow, MD The Feinstein Institute for Medical Research Using the Cholinergic Anti-Inflammatory Pathway to treat Rheum Add to Reading List Source URL: ww2.rheumatology.org Language: English - Date: 2012-11-20 16:33:31 Rheumatologists Rheumatology Arthritis Rheumatoid arthritis Peter K. Gregersen TNF inhibitor Biologic Thomas McPherson Brown Michael D. Lockshin Medicine Health Anatomy
932	The Reagan-Udall Foundation (RUF) is seeking nominations for its Innovation in Medical Evidence Development and Surveillance (IMEDS) program Scientific Advisory Committee (SAC), which will provide independent review of a Add to Reading List Source URL: www.reaganudall.org Language: English - Date: 2013-06-06 13:56:31 Pharmaceutical sciences Medicine Clinical pharmacology Therapeutics United States Public Health Service Center for Biologics Evaluation and Research Reagan-Udall Foundation Biologic Food and Drug Administration Pharmacology Clinical research
933	November 28, 2014 Sleep Prosthodontics: A Biologic Approach to Occlusion, Wear & TMD Who are the individuals, both personal and professional, that are being impacted by airway issues? What is the correlation between Slee Add to Reading List Source URL: www.winnipegdentalsociety.org Language: English - Date: 2014-07-10 12:29:00 Dentistry Outline of dentistry and oral health Obstructive sleep apnea Sleep apnea Prosthodontics Bruxism Oral appliance Sleep disorders Medicine Health
934	October 9, 2009: Cellular, Tissue and Gene Therapeis Advisory Committee Waiver to Allow Participation in a Food and Drug Administration Advisory Committee Add to Reading List Source URL: www.fda.gov Language: English Cell biology Developmental biology Pharmacology Cell therapy Embryonic stem cell Biologic Center for Biologics Evaluation and Research Regenerative medicine Center for Stem Cell and Regenerative Medicine Biology Biotechnology Stem cells
935	BIOLOGICS The FY 2010 program level budget submission for the FDA Biologics Program is $305,731,000. The following table shows a three-year funding history for the Biologics Program. FDA Program Resources Table FY 2008 Add to Reading List Source URL: www.fda.gov Language: English Biotechnology Center for Biologics Evaluation and Research Biologic Prescription Drug User Fee Act Influenza vaccine Vaccine Office of Regulatory Affairs Influenza Adverse effect Food and Drug Administration Medicine Health
936	Appendix 1 APLB - Advertising and Promotional Labeling Branch BiMo - Bioresearch Monitoring Branch, Division of Inspection and Surveillance, Office of Compliance and Biologics Quality BLA - biological license application Add to Reading List Source URL: www.fda.gov Language: English Health Biologic License Application New Drug Application Office of Regulatory Affairs Biologic Biostatistics Regulatory affairs Center for Biologics Evaluation and Research Food and Drug Administration Medicine Biotechnology
937	YEARLY BIOLOGIC PRODUCT REPORT TEMPLATE CONTEXT Yearly Biologic Product Report (YBPR) is a requirement that applies to Schedule D (biologic) drugs assigned to Evaluation Groups 2, 3, and 4, as defined in Health Canada gu Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2014-04-11 09:57:58 Materials science Reliability engineering Survival analysis Biologic Science Pharmaceutical sciences Systems science Pharmacology Systems engineering Failure
938	IMMUNOLOGICAL RELATIONSHIPS OF CELL CONSTITUENTS OF PNEUMOCOCCUS. SECOND BY OSWALD Add to Reading List Source URL: profiles.nlm.nih.gov Language: English - Date: 2005-10-13 12:36:02 Glycoproteins Biotechnology Antigen Polyclonal antibodies Antibody Bacterial capsule Monoclonal antibodies Biologic Avery–MacLeod–McCarty experiment Immune system Biology Immunology
939	INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES Add to Reading List Source URL: www.pmda.go.jp Language: English - Date: 2014-07-13 20:40:50 Research Clinical research Science Drug discovery Food and Drug Administration Validation Clinical trial Biologic Drug development Pharmacology Pharmaceutical sciences Pharmaceutical industry
940	Chapter 8 Combination Products Suzanne O’Shea, Baker & Daniels, LLP, Indianapolis, IN Key Points 䡲 A combination product comprises two or more different types of regulated components. Add to Reading List Source URL: www.faegrebd.com Language: English - Date: 2012-02-23 12:09:57 Health Pharmaceutical industry Pharmacology Clinical research Pharmaceuticals policy Center for Biologics Evaluation and Research Medical device Biologic Center for Drug Evaluation and Research Food and Drug Administration Medicine Pharmaceutical sciences

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