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Biosimilar
Results: 639

#	Item
301	Center for Drug Evaluation and Research Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology August 8, 2012 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Clinical research Quality Dissolution testing Bioequivalence Food and Drug Administration In vivo Quality by Design Biosimilar Pharmaceutical sciences Pharmaceutical industry Pharmacology
302	Microsoft Word - FINAL 2012 Peds ODAC briefing document[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Piperazines Pharmaceutical industry Food and Drug Administration United States Public Health Service New Drug Application Biosimilar Food and Drug Administration Amendments Act Moxifloxacin Pharmacology Pharmaceutical sciences Clinical research
303	June 3, 2014 The Honorable Margaret Hamburg, Commissioner The Food and Drug Administration[removed]New Hampshire Avenue Silver Spring, MD 20993 Add to Reading List Source URL: rarediseases.org Language: English - Date: 2014-06-03 10:52:31 Medicine Clinical research Biosimilar Biotechnology Drugs Biologic Pharmaceutical industry Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Pharmacology Pharmaceutical sciences Food and Drug Administration
304	Microsoft Word[removed]Biosimilars Guidance Comments.docx Add to Reading List Source URL: www.usp.org Language: English - Date: 2013-01-09 13:11:05 Drugs Food and Drug Administration Biosimilar Biotechnology United States Pharmacopeia USP Federal Food Drug and Cosmetic Act Biologic FDCA Medicine Pharmaceutical sciences Pharmacology
305	January 14, 2010 The Honorable Harry Reid Majority Leader United States Senate Washington, DC 20510 Add to Reading List Source URL: mdausa.org Language: English - Date: 2013-04-10 17:25:22 Biotechnology Drugs Stem cells Biologic American Association of Neurological Surgeons ALS Association Alliance for Aging Research New York Stem Cell Foundation Muscular Dystrophy Association Medicine Biology Biosimilar
306	RegulatoryAffairs-2014_ScientificProgram.indd Add to Reading List Source URL: regulatoryaffairs2014.pharmaceuticalconferences.com Language: English - Date: 2014-09-09 12:03:18 Research Pharmacology Clinical research Validity Food and Drug Administration Validation Regulatory affairs Biosimilar Clinical trial Pharmaceutical sciences Medicine Pharmaceutical industry
307	Regulatory perspectives on the manufacture and characterization of biotechnology products during pharmaceutical development Add to Reading List Source URL: sbir.cancer.gov Language: English - Date: 2013-06-04 14:38:24 Pharmaceutical sciences Clinical research Biotechnology Food and Drug Administration Therapeutics United States Public Health Service Immunogenicity Monoclonal antibodies Biosimilar Immunology Medicine Pharmacology
308	Subsequent entry biologics in Canada The case for multi-sector collaboration Roundtable Summary Report March[removed]Subsequent entry biologics in Canada\| 1 Add to Reading List Source URL: ppforum.ca Language: English - Date: 2014-04-11 07:09:16 Health Biosimilar Biologic Adverse effect Pharmacovigilance Pharmacology Medicine Pharmaceutical sciences
309	Public Stakeholder Meeting on Biosimilars User Fee Program, June 24, 2011 Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical sciences Biosimilar Biotechnology Drugs Biologic Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Food and Drug Administration Clinical research Medicine
310	Biopharmaceutical Discovery and Development _______________________________________________________________________________________________________________________________________________________________________________ Add to Reading List Source URL: www.agilent.com Language: English - Date: 2014-08-26 10:56:35 Agilent Technologies Biosimilar Pharmaceutical industry Drug development Biopharmaceutical Biologic Food and Drug Administration Pharmacology Pharmaceutical sciences Clinical research

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