Biologic

Results: 1831



#Item
601Immunology / Anatomy / Vaccination / Cancer immunotherapy / Monoclonal antibodies / Biologic / Oncolytic virus / MedImmune / Vaccine / Medicine / Biology / Immune system

Microsoft PowerPoint - Doroshow.pptx

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Source URL: deainfo.nci.nih.gov

Language: English - Date: 2012-02-03 08:49:45
602Pharmaceutical sciences / Biotechnology / Pharmaceutical industry / Biologic / Specification / Mucopolysaccharidosis / Test method / Recombinant DNA / BioMarin Pharmaceutical / Science / Pharmacology / Quality

Review - Laronidase (Aldurazyme)

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Source URL: www.fda.gov

Language: English
603Clinical research / Food and Drug Administration / Center for Biologics Evaluation and Research / Influenza / Pneumococcal conjugate vaccine / Biologic / Wyeth / Biotechnology / Pharmacology / Medicine

FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH MEMORANDUM Minutes of Face-to-Face Meeting with Sponsor

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Source URL: www.fda.gov

Language: English
604Clinical research / Food and Drug Administration / Biosimilar / Biotechnology / Drugs / Pharmaceuticals policy / Biologic / Federal Food /  Drug /  and Cosmetic Act / Medicine / Pharmaceutical sciences / Pharmacology

FY 2013 BsUFA Financial Report

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Source URL: www.fda.gov

Language: English
605Immunology / Biotechnology / Amgen / Etanercept / Immunosuppressants / Immunogenicity / Biosimilar / Biologic / Food and Drug Administration / Medicine / Clinical research / Pharmacology

November 12,2004 VIA H-AND DELIVERY Division of Dockets Management U.S. Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852

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Source URL: www.fda.gov

Language: English - Date: 2006-03-17 17:27:56
606Pharmaceutical industry / Clinical research / Food and Drug Administration / Biosimilar / Drugs / Biologic / Validation / Clinical trial / Abbreviated New Drug Application / Pharmaceutical sciences / Pharmacology / Research

Caroline J Loew, PhD Vice President Scientific and Regulatory Affairs 12 November 2004 Division of Dockets Management

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Source URL: www.fda.gov

Language: English - Date: 2006-03-17 17:28:23
607Biosimilar / Biotechnology / Drugs / Declaratory judgment / Biologic / Etanercept / Novartis / Food and Drug Administration / Patent infringement / Pharmacology / Clinical research / Pharmaceutical sciences

Supplement to the Los Angeles and San Francisco AUGUST 27, 2014 BIOTECH: THE BATTLE OVER BIOSIMILARS

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Source URL: www.morganlewis.com

Language: English - Date: 2014-08-29 13:41:53
608Microbiology / Virology / Vaccines / Biotechnology / Cell culture / Virus / Influenza / Biologic / Immune system / Biology / Medicine / Vaccination

Guidance for Industry- Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications

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Source URL: www.fda.gov.

Language: English
609Health / Biotechnology / Biologic License Application / Center for Biologics Evaluation and Research / Biologic / Genentech / Adverse effect / Pharmacology / Medicine / Food and Drug Administration

DEPARTMENT OF HEALTH & HUMAN

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Source URL: www.fda.gov

Language: English
610Clinical research / Pharmaceuticals policy / Pharmacy / Health Products and Food Branch / Active ingredient / Drug discovery / Biologic / Ingredient / Therapeutic Products Directorate / Pharmaceutical sciences / Pharmacology / Health Canada

Policy: Interpretation of "Identical Medicinal Ingredients"

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Source URL: hc-sc.gc.ca

Language: English - Date: 2013-07-12 14:25:51
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