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Biosimilar
Results: 639

#	Item
531	Consumer Health Information www.fda.gov/consumer/updates/biologics062608.html www.fda.gov/consumer Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmacology Center for Biologics Evaluation and Research Influenza Biologic Center for Drug Evaluation and Research Adverse Event Reporting System Biologics Control Act Biosimilar Food and Drug Administration Biotechnology Medicine
532	H. R. 3590—[removed]TITLE XI.—Title XI of the Social Security Act (42 U.S.C[removed]et seq.) is amended— (A) in section 1128(h)(3)— (i) by inserting ‘‘subtitle 1 of’’ before ‘‘title XX’’; and Add to Reading List Source URL: www.fda.gov Language: English Biosimilar Patent Law Government Ceylon Citizenship Act Business Intellectual property law Patent infringement Patent prosecution
533	Biosimilar Biological Products 2013 Clinical Investigator Course Sue Lim, M.D. Senior Staff Fellow OND Therapeutic Biologics and Biosimilars Team/CDER/FDA Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Biosimilar Biotechnology Drugs Biologic Pharmaceutical industry Food and Drug Administration Drug discovery Immunogenicity Pharmaceutical sciences Pharmacology Clinical research
534	Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceutical industry Food and Drug Administration Biotechnology Biosimilar Biologic Validation Pharmacokinetics New Drug Application Pharmaceutical sciences Pharmacology Medicine
535	Microsoft Word[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Biotechnology Clinical research Pharmaceutical industry Biosimilar Biologic New Drug Application Center for Biologics Evaluation and Research Investigational New Drug Food and Drug Administration Pharmaceutical sciences Medicine
536	Microsoft Word - 10519dft.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Biosimilar Center for Biologics Evaluation and Research Biologic New Drug Application Investigational New Drug Center for Drug Evaluation and Research Food and Drug Administration Medicine Health
537	PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017 Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceuticals policy Biosimilar Biotechnology Drugs Prescription Drug User Fee Act FDA Special Protocol Assessment Clinical trial Regulatory requirement Pharmaceutical sciences Pharmacology Clinical research
538	Biopress selection 9 June 2006 Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2006-07-04 12:59:09 Environmental issues Genetically modified organism Molecular biology Genetically modified food Biosimilar Agricultural policy Biology Genetic engineering Biotechnology
539	Biopress selection January Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2006-05-08 10:17:21 Genetic engineering Biotechnology Food industry Genetically modified food Food security Biosimilar Biology Food and drink Environment Environmental issues
540	18 February 2013 Reference: DGSanco13004 BY E-MAIL [removed] Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:30:27 Science Clinical research Pharmaceutical industry Design of experiments Evaluation methods Pharmacovigilance Clinical trial Vaccine Biosimilar Pharmaceutical sciences Pharmacology Research

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