Biologic

Results: 1831



#Item
901Biosimilar / Hospira / Food and Drug Administration / Biologic / Clinical pharmacy / Pharming / Pharmaceutical industry / FDA Fast Track Development Program / Clinical trial / Pharmacology / Pharmaceutical sciences / Clinical research

Volume 11, Number 8 August 2014 News and Strategies for Managing High-Cost Specialty Products

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Source URL: aishealth.com

Language: English - Date: 2014-08-15 14:40:44
902Health / Clinical research / Pharmaceuticals policy / Pharmaceutical industry / Prescription Drug User Fee Act / European Medicines Agency / FDA Fast Track Development Program / Biologic / Clinical trial / Food and Drug Administration / Pharmaceutical sciences / Pharmacology

Report: Complex Issues in Developing Drugs and Biological Products for Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases

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Source URL: www.fda.gov.

Language: English
903Pharmacology / Biosimilar / New Drug Application / Biologic License Application / Center for Biologics Evaluation and Research / Generic drug / Center for Drug Evaluation and Research / Biologic / Drug Price Competition and Patent Term Restoration Act / Food and Drug Administration / Medicine / Pharmaceutical sciences

VIA HAND DELIVERY Division of Dockets Management U.S. Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD[removed]Re:

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Source URL: www.fda.gov

Language: English - Date: 2005-05-04 15:43:27
904Medicine / Clinical research / Center for Biologics Evaluation and Research / Influenza / Center for Drug Evaluation and Research / Biologic / Biologics Control Act / Food and Drug Administration / Biotechnology / Pharmacology

Staff Manual Guide[removed]

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Source URL: www.fda.gov

Language: English
905Clinical research / Pharmaceutical industry / Clinical pharmacology / Quality by Design / Regulatory requirement / Center for Biologics Evaluation and Research / New Drug Application / Biologic / Center for Drug Evaluation and Research / Pharmaceutical sciences / Pharmacology / Food and Drug Administration

Influence of Global Regulatory Landscape on Drug Development: US Perspective

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Source URL: www.fda.gov

Language: English
906Monoclonal antibodies / Centocor / Psoriasis / Ustekinumab / Infliximab / Biologic / Adalimumab / Methadone / Chemotherapy / Immunosuppressants / Medicine / Pharmacology

P A T I E N T I N F O R M A T I O N

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Source URL: novascotia.ca

Language: English - Date: 2013-10-09 13:42:28
907Health / Medicine / Pharmaceuticals policy / Food law / Food and Drug Administration Modernization Act / Center for Biologics Evaluation and Research / Center for Drug Evaluation and Research / Off-label use / Biologic / Food and Drug Administration / Pharmacology / Pharmaceutical sciences

PDF Document

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Source URL: www.fda.gov

Language: English - Date: 1998-09-10 14:51:09
908Pharmacology / 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

Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act

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Source URL: www.fda.gov

Language: English
909Clinical research / Health / Clinical pharmacology / Therapeutics / United States Public Health Service / Center for Biologics Evaluation and Research / Structured Product Labeling / Biologic License Application / Biologic / Food and Drug Administration / Medicine / Pharmacology

Microsoft Word - 2920A0CD.doc

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Source URL: www.fda.gov

Language: English
910Biotechnology / Immune system / Pharmacology / Immunogenicity / Hyatt / Biomarker / Monoclonal antibody therapy / Monoclonal antibodies / Biologic / Immunology / Medicine / Biology

250 First Avenue, Suite 300 • Needham, MA 02494 • P: [removed] • F: [removed]CONFERENCE CALENDAR 2014 EVENTS SEPTEMBER 2014 Leaders in Biobanking Congress

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Source URL: www.scopesummit.com

Language: English - Date: 2014-09-08 10:48:23
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