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#	Item
961	[Product name – Report year] [Sponsor] YEARLY BIOLOGIC PRODUCT REPORT (YBPR) Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2014-04-11 09:58:23 Specification Standards Technical communication Systems engineering process Technology Management Form Systems engineering Product development Quality
962	July 1, 2014 Commissioner Margaret A. Hamburg Food and Drug Administration[removed]New Hampshire Avenue Silver Spring, MD 20993 Add to Reading List Source URL: www.gphaonline.org Language: English - Date: 2014-07-01 09:21:44 Clinical research Biosimilar Biotechnology Drugs Biologic Pharmaceutical care management association Food and Drug Administration Center for Drug Evaluation and Research Patient Protection and Affordable Care Act Medicine Health Pharmacology
963	ICH Topic Q5C - Quality of Biotechnological Products: Stabilit Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-12 14:26:05 Technology Food and Drug Administration Pharmaceutical industry Clinical research Pharmaceuticals policy Regulatory requirement Biologic Medical device Clinical trial Medicine Health Pharmacology
964	Biologics and Genetic Therapies Directorate EXPERT ADVISORY COMMITTEE ON CELLS, TISSUES AND ORGANS TERMS OF REFERENCE I. Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-07-09 10:28:51 Childbirth Developmental biology Biologic Pharmacology Committee Regenerative medicine 41st Canadian Parliament Cord blood Biology Biotechnology Stem cells
965	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring MD 20993 Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Stem cells Emerging technologies Gene therapy Stem cell Center for Biologics Evaluation and Research Food and Drug Administration Biologic Outline of cell biology Biology Biotechnology Cell biology
966	P4.30 CDA Langley PSOLAR Malignancies_v08_FINAL.PPTX Add to Reading List Source URL: www.dermatology.ca Language: English - Date: 2014-07-30 15:52:43 Monoclonal antibodies Immunology Centocor Psoriasis Ustekinumab Biologic Etanercept Infliximab Adalimumab Medicine Immunosuppressants Pharmacology
967	P4.31_Bissonnette_PSOLAR_MACE_CDA_v05_final.pptx Add to Reading List Source URL: www.dermatology.ca Language: English - Date: 2014-07-30 15:52:46 Monoclonal antibodies Immunology Centocor Psoriasis Ustekinumab Biologic Infliximab Etanercept TNF inhibitor Immunosuppressants Pharmacology Medicine
968	Regulatory Considerations for the Manufacture of Investigational Vaccines for Clinical Trials Add to Reading List Source URL: www.fda.gov. Language: English Pharmacology Clinical research Pharmaceutical industry Vaccination Food and Drug Administration Center for Biologics Evaluation and Research Vaccine Validation Biologic Biotechnology Medicine Pharmaceutical sciences
969	THE CHEMICAL NATURE OF IMMUNE SUBSTANCES Add to Reading List Source URL: profiles.nlm.nih.gov Language: English - Date: 2005-10-13 12:47:34 Antibody Monoclonal antibodies Polyclonal antibodies Protein Michael Heidelberger Pepsin Hapten Biologic Polyclonal B cell response Biology Immune system Antigen
970	national institutes of health While conducting research subject to the NIH Guidelines, the PI must: office of biotechnology activities Add to Reading List Source URL: www.ehs.columbia.edu Language: English - Date: 2013-08-28 11:35:39 Biotechnology Health Bethesda Maryland Cancer research Nursing research Nucleic acid Genetic engineering Biologic Biology Medicine National Institutes of Health

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