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Biologic license application
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51	Center for Biologics Evaluation and Research Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-02-19 09:37:04 Diabetes Blood banks Islet cell transplantation Transplantation medicine Year of birth missing Center for Biologics Evaluation and Research Biologic License Application James Shapiro Medicine Food and Drug Administration Health
52	Center for Biologics Evaluation and Research Biological Response Modifiers Advisory Committee SUMMARY MINUTES Meeting #36, October 9-10, 2003 Holiday Inn, Gaithersburg, MD Add to Reading List Source URL: www.fda.gov Language: English - Date: 2004-02-19 09:37:05 Diabetes Blood banks Islet cell transplantation Transplantation medicine Year of birth missing Center for Biologics Evaluation and Research Biologic License Application James Shapiro Medicine Food and Drug Administration Health
53	Microsoft Word - Final Summary.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Therapeutics United States Public Health Service Biologic License Application Clinical investigator Center for Biologics Evaluation and Research Food and Drug Administration Medicine Clinical research
54	FACSIMILE TRANSMISSION RECORD - GLASSIA, June 11, 2010 Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Quality Clinical research Pharmaceutical industry Validation Biologic License Application Center for Biologics Evaluation and Research Fax Biologic Food and Drug Administration Technology Pharmaceutical sciences
55	FDA Electronic Submissions Gateway (ESG) Add to Reading List Source URL: www.fda.gov Language: English Research Medicine Pharmaceutical sciences Electronic Common Technical Document AS2 New Drug Application Electronic submission Title 21 CFR Part 11 Biologic License Application Food and Drug Administration Clinical research Pharmaceutical industry
56	Guidance for Industry and FDA Staff: Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences New Drug Application Premarket approval Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Biologic License Application Investigational New Drug Title 21 of the Code of Federal Regulations Investigational Device Exemption Food and Drug Administration Medicine Health
57	New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals As of December 31, 2012 Selection Criteria: User Response: Start Date: [removed]End Date: [removed] Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Piperazines Eli Lilly and Company New Drug Application Pharmaceutical industry Tapentadol Levofloxacin Ofloxacin FDA Fast Track Development Program Chemistry Pharmacology Organic chemistry
58	DOCUMENT INFORMATION PAGE Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2009-08-07 11:32:47 Biology Botulinum toxin Structured Product Labeling Allergan Botulism Spasmodic torticollis Federal Food Drug and Cosmetic Act Center for Drug Evaluation and Research Biologic License Application Medicine Food and Drug Administration Health
59	FOOD AND DRUG ADMINISTRATION Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Biologic License Application Monomethyl auristatin E Brentuximab vedotin Clinical research Food and Drug Administration
60	New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements 2008 Add to Reading List Source URL: www.fda.gov Language: English Bristol-Myers Squibb Lactams Piperazines Quinolones Chemistry Organic chemistry Aripiprazole