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Articles (10)

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1-10 of 10 results for BLA Approved

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Select article: Ustekinumab

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Research article

First published 2010-4

Ustekinumab

Dennis J. Cada, Terri L. Levien, Danial E. Baker

Hospital Pharmacy

Select article: Emerging Trends in US Oncological Approvals: A 13-Year Review (1999-2011)

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Research article

First published 2012-5

Emerging Trends in US Oncological Approvals: A 13-Year Review (1999-2011)

Jing Huang, Wenze Zhang, Debra Bowen [...]

Therapeutic Innovation & Regulatory Science

Select article: The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis

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Research article

First published 2007-9

The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis

James B. Graham, Ernst R. Berndt

Therapeutic Innovation & Regulatory Science

Select article: Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009

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Research article

First published 2013-07

Participation of Women and Sex Analyses in Late-Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the FDA in 2007–2009

Rita Poon, Keshav Khanijow, Sphoorti Umarjee [...]

Journal of Women's Health

Select article: Factors Associated with Multiple FDA Review Cycles and Approval Phase Times

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Other

First published 2009-3

Factors Associated with Multiple FDA Review Cycles and Approval Phase Times

Joseph A. DiMasi, Laura Faden

Therapeutic Innovation & Regulatory Science

Select article: The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

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Other

First published 2001-1

The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

Janice M. Reichert, Jennifer Chee, Claire S. Kotzampaltiris

Therapeutic Innovation & Regulatory Science

Select article: Supplemental Applications Proposing Labeling Changes for Approved Drugs,Biologics,and Medical Devices [excerpts]

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Research article

First published 2008-04

Supplemental Applications Proposing Labeling Changes for Approved Drugs,Biologics,and Medical Devices [excerpts]

Biotechnology Law Report

Select article: Juries Trump FDA in Writing Drug Labels;FDA Grants Clinical Trial Permission for Human Embryonic Stem Cells;Alerts Issued for Two Biotechnology Products;Japanese Rheumatoid Arthritis Drug Approved in Europe;FDA Criticizes Humira Ad;Amgen's BLA for Bone Drug Accepted;Rules for Claiming Health Benefits from Food and Supplements

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Research article

First published 2009-04

Juries Trump FDA in Writing Drug Labels;FDA Grants Clinical Trial Permission for Human Embryonic Stem Cells;Alerts Issued for Two Biotechnology Products;Japanese Rheumatoid Arthritis Drug Approved in Europe;FDA Criticizes Humira Ad;Amgen's BLA for Bone Drug Accepted;Rules for Claiming Health Benefits from Food and Supplements

Biotechnology Law Report

Select article: Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-Derived Pharmaceuticals

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Other

First published 2000-7

Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-Derived Pharmaceuticals

Robert L. Zeid

Therapeutic Innovation & Regulatory Science

Select article: Genomic and Phenotypic Analysis of Persistent Carbapenem-Resistant Klebsiella pneumoniae Isolates from a 5-Year Hospitalized Patient

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Research article

First published 2021-08

Genomic and Phenotypic Analysis of Persistent Carbapenem-Resistant Klebsiella pneumoniae Isolates from a 5-Year Hospitalized Patient

Zhiqiang Yang, Qiaoling Sun, Shang Chen [...]

Microbial Drug Resistance

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