Biologic

Results: 1831



#Item
721Immunology / Abatacept / Anakinra / Rheumatoid arthritis / Adalimumab / Leflunomide / Etanercept / CTLA-4 / Biologic / Immunosuppressants / Medicine / Pharmacology

----------------------DOSAGE FORMS AND STRENGTHS--------------------• 250 mg single-use vial (3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ORENCIA safely a

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Source URL: www.fda.gov

Language: English
722Arthritis / Connective tissue diseases / National Arthritis Awareness Program / Juvenile idiopathic arthritis / Rheumatoid arthritis / Osteoarthritis / Rheumatism / Biologic / Arthritis Foundation / Health / Medicine / Rheumatology

ARTHRITIS ALLIANCE OF CANADA NEWSLETTER March 2014 Inside this issue: AAC IA MOC Update............................1 CHU de Quebec......................................1

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Source URL: www.arthritisalliance.ca

Language: English - Date: 2014-03-27 18:59:23
723Immune system / Immunology / Food and Drug Administration / Blood products / Biotechnology / Center for Biologics Evaluation and Research / Monoclonal antibodies / Biologic / Immunoglobulin E / Biology / Anatomy / Medicine

a1Document; a2Document; a3Document; a4Document; a5Document; a6Document; a7Document; a8Document; a1Technical; a2Technical; a3Tech

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Source URL: www.fda.gov

Language: English - Date: 1998-03-12 09:33:12
724Medicine / Biotechnology / Glycoproteins / Monoclonal antibody therapy / Monoclonal antibodies / Humanized antibody / Neutralizing antibody / Biologic / Antibody / Biology / Immunology / Immune system

Next-Generation Monoclonal Antibodies: Challenges and Opportunities Center for Biosecurity of UPMC Final Report – February 2013

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Source URL: www.upmchealthsecurity.org

Language: English
725Pharmaceutical sciences / Pharmacology / Therapeutics / United States Public Health Service / Paperwork Reduction Act / Electronic Common Technical Document / Biologic License Application / New Drug Application / Food and Drug Administration / Clinical research / Research

DATE SUBMITTED TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE (21 CFR[removed])

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Source URL: www.fda.gov.

Language: English
726Health / Clinical research / Food and Drug Administration / Clinical pharmacology / United States Public Health Service / Biologic / Center for Biologics Evaluation and Research / Medical privacy / Surveillance / Ethics / Pharmacology / Privacy

MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Biologics Evaluation and Research

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Source URL: www.fda.gov

Language: English
727Biosimilar / Biologic / Etanercept / Clinical research / Dai-ichi / Pharmacology / Daiichi Sankyo / Medicine

Microsoft Word - 20140818_エタネルセプトBS_P3開始_EN_fin.doc

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Source URL: www.daiichisankyo.com

Language: English - Date: 2015-03-31 00:51:01
728Medicine / Drug safety / Health / Clinical research / New Drug Application / Investigational New Drug / Biologic License Application / Drug Master File / Food and Drug Administration / Pharmaceutical industry / Pharmaceutical sciences

INSTRUCTIONS FOR FILLING OUT FORM FDA 356h – APPLICATION TO MARKET A NEW OR ABBREVIATED NEW DRUG OR BIOLOGIC FOR HUMAN USE (The field numbers below correspond to the numbered boxes on the Form FDA 356h) NOTE: Please

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Source URL: www.fda.gov.

Language: English
729Arthritis / Rheumatoid arthritis / Juvenile idiopathic arthritis / Childhood arthritis / Spondyloarthropathy / Biologic / Rheumatism / Osteoarthritis / Ankylosing spondylitis / Health / Medicine / Rheumatology

ARTHRITIS ALLIANCE OF CANADA NEWSLETTER March 27, 2013 Progress in Models of Care A top priority of the Arthritis Alliance is to enhance the quality of care for patients with arthritis through improvements in how care is

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Source URL: www.arthritisalliance.ca

Language: English - Date: 2014-03-27 19:37:37
730Pharmaceutical sciences / Prescription Drug User Fee Act / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Biologic / Food and Drug Administration / Medicine / Health

Guidance for Industry Formal Dispute Resolution: Appeals Above the Division Level U.S. Department of Health and Human Services Food and Drug Administration

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Source URL: www.fda.gov.

Language: English
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