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#	Item
971	Date: May 28, 2013 From: Zhiping Ye, M.D., Ph.D., Chair of the Review Committee Goutam Sen, Ph.D., Regulatory Project Manager CDR Edward W. Wolfgang, Regulatory Project Manager BLA/ STN: [removed]Applicant Name: Sanof Add to Reading List Source URL: www.fda.gov Language: English Health Influenza vaccines Influenza Orthomyxoviridae Fluzone FluMist Center for Biologics Evaluation and Research Flu season Influenza research Vaccines Medicine Vaccination
972	Summary Basis for Regulatory Action (SBRA) Date: July 12, 2011 From: Rana Chattopadhyay, Chair of the Review Committee BLA/ STN#: [removed]Applicant Name: Sanofi Pasteur Limited Date of Submission: September 29, 2010 Add to Reading List Source URL: www.fda.gov Language: English Bacterial diseases Biology DPT vaccine Pertussis vaccine Vaccination Pertussis Tetanus Sanofi Pasteur DTAP Vaccines Medicine Health
973	Clinical Review Memo of BLA Supplement for Human Papillomavirus Vaccine Add to Reading List Source URL: www.fda.gov Language: English Gardasil Human papillomavirus Cervarix Wart Cervical cancer HPV vaccine Vaginal intraepithelial neoplasia Genital wart Vulvar intraepithelial neoplasia Papillomavirus Medicine Microbiology
974	BLA[removed]KRYSTEXXA® (pegloticase) PEGylated uric acid specific enzyme Savient Pharmaceuticals, Inc. 400 Crossing Boulevard Bridgewater, NJ 08807 Add to Reading List Source URL: www.fda.gov Language: English Pegloticase Piperazines Uric acid Febuxostat Hyperuricemia Norfloxacin Anaphylaxis Glucose-6-phosphate dehydrogenase deficiency Chemistry Medicine Organic chemistry
975	CLINICAL PHARMACOLOGY BLA REVIEW Add to Reading List Source URL: www.fda.gov Language: English Pharmacokinetics Factor VIII Norfloxacin Haemophilia Blood Pharmaceutical sciences Von Willebrand disease
976	BLA EFFICACY SUPPLEMENT MEDICAL FINAL REVIEW MEMO OF SPONSOR’S RESPONSE TO COMPLETE REVIEW LETTER Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Clinical research Pharmaceutical industry Food and Drug Administration Adverse event Adverse effect Clinical trial Center for Biologics Evaluation and Research Pharmacology Medicine Health
977	Initial REMS Approved: [removed]Most Recent Modification: October/2013 BLA[removed]and BLA[removed] Add to Reading List Source URL: www.fda.gov Language: English Rheumatoid arthritis Genentech Health Immunosuppressants Anatomy Tocilizumab
978	Initial REMS Approval: [removed]Most Recent Modification: [removed]BLA[removed]STELARA® (ustekinumab) Human interleukin 12 and 23 antagonist RISK EVALUATION AND MITIGATION STRATEGY (REMS) Add to Reading List Source URL: www.fda.gov Language: English Immunology Pharmacology Tuberculosis Psoriasis Centocor Ustekinumab Tuberculosis treatment Latent tuberculosis Psoriatic arthritis Medicine Immunosuppressants Monoclonal antibodies
979	Initial REMS approval: [removed]Most recent modification: [removed]BLA[removed]MYALEPT™ (metreleptin) Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical sciences Clinical pharmacology Medical prescription Patient safety Eli Lilly and Company Leptin Methadone Pharmacy Chemistry Pharmacology Peptide hormones
980	ECQA Certified Terminology Manager - Advanced Online course, April – June 2014 Introduction - ECQA, Certified Terminology Manager – Advanced and online course Date: 3 April[removed]from 9.00 to[removed]a.m. Webinar: Bla Add to Reading List Source URL: www.termnet.org Language: English - Date: 2014-06-17 18:35:41 EMC EA/EB Terminology CTM Rail transport Land transport Rolling stock

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