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521	Microsoft Word - 13Dong.doc Add to Reading List Source URL: www.iip.or.jp Language: English - Date: 2011-06-12 22:30:10 Patent law Pharmaceuticals policy Pharmaceutical industry Biosimilar Drugs Drug Price Competition and Patent Term Restoration Act Biologic Generic drug Food and Drug Administration Pharmaceutical sciences Pharmacology Clinical research
522	EU/US administrative simplification Workshop Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:04:56 Pharmaceutical industry Quality European Medicines Agency Food and Drug Administration Validation Biosimilar Common Technical Document Clinical investigator Pharmaceutical sciences Pharmacology Clinical research
523	Presentation Slide Template (DIA) Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceuticals policy Prescription Drug User Fee Act Biosimilar Fee Pharmaceutical sciences Food and Drug Administration Pharmacology
524	Biosimilar Biological Products Rachel E. Sherman, MD, MPH Associate Director for Medical Policy Center for Drug Evaluation and Research Biosimilar Guidance Webinar February 15, 2012 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Food and Drug Administration Pharmaceuticals policy Clinical research Biosimilar Biologic New Drug Application Immunogenicity Generic drug Pharmaceutical sciences Pharmacology Medicine
525	8883 Federal Register / Vol. 77, No[removed]Wednesday, February 15, [removed]Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 351(k) Application for biosimilars (42 U.S.C. 262(k[removed]l)(6)(C) ............. Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 13:09:03 Health Biosimilar New Drug Application Biologic License Application Center for Biologics Evaluation and Research Biologic Investigational New Drug Food and Drug Administration Medicine Pharmaceutical sciences
526	sroberts on DSK5SPTVN1PROD with NOTICES[removed]Federal Register / Vol. 77, No[removed]Wednesday, February 15, [removed]Notices Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 13:09:03 Pharmaceutical sciences Biosimilar New Drug Application Biologic License Application Investigational New Drug Center for Biologics Evaluation and Research Structured Product Labeling Title 21 CFR Part 11 Food and Drug Administration Medicine Health
527	Federal Register / Vol. 77, No[removed]Wednesday, February 15, [removed]Notices manufactured, processed, packed, or held).1 All product applications should contain a complete and thorough Chemistry, Manufacturing, and Contro Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-05-23 13:09:03 Health Research Clinical research Pharmacology Pharmaceutical industry Biosimilar New Drug Application Biologic License Application Investigational New Drug Food and Drug Administration Medicine Drug safety
528	Federal Register / Vol. 77, No[removed]Wednesday, August 1, [removed]Notices tkelley on DSK3SPTVN1PROD with NOTICES Administration, P.O. Box[removed], St. Louis, MO 63195–3877. Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2012-08-01 03:23:01 Health Pharmacology Prescription Drug User Fee Act Biosimilar Federal Food Drug and Cosmetic Act Generic drug Investigational New Drug Fee Animal drugs Food and Drug Administration Medicine Pharmaceuticals policy
529	Therapeutic Biologic Drugs - Part 1 Add to Reading List Source URL: www.fda.gov Language: English Biotechnology Drugs Biosimilar Biologic Pharmaceutical industry Pharmaceuticals policy Food and Drug Administration Generic drug Pharmaceutical sciences Pharmacology Clinical research
530	Federal Register / Vol. 78, No[removed]Monday, April 1, [removed]Notices Review Officer, CDC, 4770 Buford Highway NE., Mailstop F–46, Atlanta, Georgia 30341, Telephone: ([removed]– 3585, [removed]. The Director, Manage Add to Reading List Source URL: www.gpo.gov Language: English - Date: 2013-03-30 01:59:54 Pharmacology Food and Drug Administration United States Public Health Service Drug safety Center for Biologics Evaluation and Research Biosimilar United States Department of Health and Human Services Biologic Centers for Disease Control and Prevention Medicine Health Pharmaceutical sciences

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