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Biosimilar
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461	Microsoft Word - 0216plen.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceutical industry Pharmacokinetics Clinical pharmacology Food and Drug Administration Bioequivalence Immunogenicity Clinical trial Biosimilar Pharmaceutical sciences Pharmacology Research
462	Microsoft Word - 0214bsc1.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Food and Drug Administration Toxicology Clinical pharmacology United States Public Health Service Center for Biologics Evaluation and Research Biologic Immunogenicity Biosimilar Pharmacology Medicine Clinical research
463	Microsoft Word - 0215bse1.doc Add to Reading List Source URL: www.fda.gov Language: English Immunology Immunogenicity Food and Drug Administration Immune system Biotechnology Antigen Biosimilar Interferon Center for Biologics Evaluation and Research Medicine Biology Pharmacology
464	Federal Register / Vol. 77, No[removed]Friday, March 2, [removed]Notices only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received commen Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 12:16:58 Pharmaceutical sciences Biosimilar Center for Biologics Evaluation and Research Health Canada New Drug Application Food and Drug Administration Medicine Health
465	Microsoft Word - 0215bse2.doc Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Immunogenicity Immunology Center for Biologics Evaluation and Research Biosimilar Medicine Clinical research Health
466	Meetings with FDA F DA Judit Milstein Chief Project Management Staff Division of Transplant and Ophthalmology Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceuticals policy Pharmaceutical industry Prescription Drug User Fee Act FDA Fast Track Development Program Drug development Biosimilar FDA Special Protocol Assessment New Drug Application Food and Drug Administration Pharmaceutical sciences Pharmacology
467	Pharmaceutical Patent Litigation Syllabus June 16-‐20, 2014 Materials: o Add to Reading List Source URL: law.unh.edu Language: English - Date: 2014-04-02 14:05:54 Biosimilar Biotechnology Drugs Abbreviated New Drug Application Waxman Food and Drug Administration FDCA Roche Products v. Bolar Pharmaceutical Pharmaceutical sciences Clinical research Pharmacology
468	Meetings with FDA F DA Judit Milstein Chief Project Management Staff Division of Transplant and Ophthalmology Products Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceuticals policy Pharmaceutical industry Prescription Drug User Fee Act FDA Fast Track Development Program Biosimilar Drug development FDA Special Protocol Assessment Food and Drug Administration Pharmaceutical sciences Pharmacology
469	Microsoft PowerPoint - Shapiro FDA REdI[removed]ppt [Read-Only] [Compatibility Mode] Add to Reading List Source URL: www.fda.gov Language: English Human behavior Pet peeve Food and Drug Administration Biosimilar Clinical research Pharmaceutical sciences Pharmacology
470	APEC Harmonization Center Update Kui Lea Park, Ph.D. Director, KFDA June 5th, 2012 Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-25 10:17:36 Biosimilar Biotechnology Drugs Asia-Pacific Economic Cooperation Global Harmonization Task Force Clinical trial Medicine Health Science

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