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Biologic License Application
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1	Microsoft Word - Savient Resubmits Biologics License Application for KRYSTEXXAdoc Add to Reading List Source URL: www.mvpharm.com Language: English - Date: 2016-07-11 16:59:56 Biotechnology Pharmacology Biology Pharmaceutical sciences Savient pharmaceuticals Pegloticase Food and Drug Administration PEGylation Forward-looking statement Biopharmaceutical Biologic license application
2	Microsoft Word - Savient Update on KRYSTEXXA BLA Filingdoc Add to Reading List Source URL: www.mvpharm.com Language: English - Date: 2016-07-11 17:00:04 Clinical research Food and Drug Administration Pharmaceutical industry Drug safety Savient pharmaceuticals Pharmaceuticals policy Pegloticase Biologic license application PEGylation Validation Pharmacovigilance Clinical trial
3	PDF Document Add to Reading List Source URL: www.biosimilarslawblog.com Language: English - Date: 2014-10-07 15:06:15 Pharmacology Biosimilar Center for Biologics Evaluation and Research Biologic License Application New Drug Application Federal Food Drug and Cosmetic Act Investigational New Drug Food and Drug Administration Medicine Health
4	BLA Complete Response Letter Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Clinical research Pharmaceutical industry Structured Product Labeling Clinical trial Biologic License Application Federal Food Drug and Cosmetic Act Food and Drug Administration Medicine Health
5	DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD[removed]MEMORANDUM Date: Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmacology Pharmaceutical industry Validity Clinical research Center for Biologics Evaluation and Research Validation Biologic License Application Assay Science Biotechnology Food and Drug Administration
6	Mixing , Diluting, or Repackaging Biological Products Outside the Scope of An Approved Biologics License Application Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Biologic License Application Center for Biologics Evaluation and Research Biologic Federal Food Drug and Cosmetic Act Center for Drug Evaluation and Research Abbreviated New Drug Application Good manufacturing practice Biosimilar Food and Drug Administration Medicine Health
7	DOCUMENT INFORMATION PAGE Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2010-10-19 08:27:08 Food and Drug Administration Pharmaceutical sciences Medical informatics Structured Product Labeling Pharmaceutical industry Adalimumab Biologic License Application BLA Center for Drug Evaluation and Research Medicine Health Pharmacology
8	./~ Public Health Service (,-4 DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2009-04-02 11:01:20 Pharmacology Pharmaceutical industry Medical informatics Biologic License Application Monoclonal antibodies Biologic Center for Drug Evaluation and Research Package insert BLA Food and Drug Administration Medicine Pharmaceutical sciences
9	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2009-12-03 09:58:12 Health Monoclonal antibodies Immunosuppressants Structured Product Labeling Adalimumab Biologic License Application Biologic Pharmaceutical drug Labeling theory Medicine Pharmacology Food and Drug Administration
10	Update Issue 2, 2004.indd Add to Reading List Source URL: www.lw.com Language: English - Date: 2004-03-24 17:54:28 Medicine Drug safety Pharmaceutical industry Medical research New Drug Application Pharmacogenomics Investigational New Drug Drug development Biologic License Application Food and Drug Administration Pharmaceutical sciences Pharmacology

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