Biosimilar

Results: 639



#Item
381Pharmaceuticals policy / Food and Drug Administration / Pharmaceutical industry / Therapeutics / Biosimilar / Anna Eshoo / Generic drug / Food and Drug Administration Amendments Act / Prescription Drug User Fee Act / Pharmaceutical sciences / Pharmacology / Clinical research

Cosponsor H.R. 2725, The Lance/Eshoo FDA Safety Over Sequestration (FDA SOS) Act Last year, Congress passed the landmark Food and Drug Administration Safety and Innovation Act of[removed]FDASIA), which included a number of

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Source URL: www.ihif.org

Language: English - Date: 2013-07-31 12:45:12
382Pharmaceutical industry / Pharmaceuticals policy / Food and Drug Administration / Biotechnology / Biologic / Pharmacy benefit management / Biosimilar / New Drug Application / Biopharmaceutical / Pharmaceutical sciences / Pharmacology / Health

Marketplace Policies, Practices, and Perspectives: 2008 Table of Contents 1. Introduction ......................................................

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Source URL: www.bms.com

Language: English - Date: 2009-03-10 18:22:07
383Biosimilar / Food and Drug Administration / Biologic / Bioequivalence / Pharmaceutical industry / Generic drug / Pharmaceutical drug / Abbreviated New Drug Application / Pharmaceutical sciences / Pharmacology / Clinical research

Challenges for Non-Biological Complex Drugs (NBCDs) Prof. dr. Daan J.A. Crommelin Emeritus prof. Utrecht University, the Netherlands [removed]

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Source URL: www.fda.gov

Language: English
384Health / Biosimilar / Biologic / Food and Drug Administration / Generic drug / Adverse effect / Pharmacovigilance / Pharmacology / Pharmaceutical sciences / Medicine

BIO Principles on Patient Safety in the Substitution of Biologic Products Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are not chemically sy

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Source URL: www.ihif.org

Language: English - Date: 2013-01-23 11:12:11
385Health / Biosimilar / Biologic / Adverse effect / Pharmacovigilance / Pharmacology / Medicine / Pharmaceutical sciences

Subsequent entry biologics in Canada The case for multi-sector collaboration Roundtable Summary Report March[removed]Subsequent entry biologics in Canada| 1

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Source URL: www.ppforum.ca

Language: English - Date: 2014-04-11 07:09:16
386Health / Pharmaceuticals policy / Food and Drug Administration / Generic drug / Biosimilar / NIPTE / Test data exclusivity / New Drug Application / Compounding / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

MAKINGDO INMAKINGDRUGS: INNOVATION POLICYAND PHARMACEUTICALMANUFACTURING

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Source URL: bclawreview.org

Language: English - Date: 2014-03-28 14:07:02
387Pharmaceutical sciences / Prescription Drug User Fee Act / Office of Regulatory Affairs / Priority review voucher / Biosimilar / Animal drugs / Fee / Food and Drug Administration / Medicine / Pharmacology

2014 FDA Justification of Estimates for Appropriations Committees

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Source URL: www.fda.gov

Language: English
388Food and Drug Administration / Pharmaceuticals policy / Food law / Therapeutics / United States Public Health Service / Animal drugs / Biosimilar / Federal Food /  Drug /  and Cosmetic Act / Medicine / Pharmacology / Health

2014 FDA Justification of Estimates for Appropriations Committees

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Source URL: www.fda.gov

Language: English
389Medicine / Drugs / Food and Drug Administration / Food law / Biosimilar / Animal drugs / Generic drug / Abbreviated New Drug Application / Fee / Pharmacology / Pharmaceutical sciences / Pharmaceuticals policy

2014 FDA Justification of Estimates for Appropriations Committees

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Source URL: www.fda.gov

Language: English
390Pharmaceutical sciences / Medical device / Biosimilar / Food Safety Modernization Act / Criticism of the Food and Drug Administration / Food Safety and Modernization Act / Food and Drug Administration / Medicine / Health

2014 FDA Justification of Estimates for Appropriations Committees

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Source URL: www.fda.gov

Language: English
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