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First published 1999-1

The Regulatory Approval Process of Animal Drugs

Stephen J. Gilbride, Michael J. McGowan

Therapeutic Innovation & Regulatory Science

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Review article

First published 2023-1

Review of novel and supplemental approvals of the targeted cancer drugs by the Food and Drug Administration in 2021

Esin Aysel Kandemir

Journal of Oncology Pharmacy Practice

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Research article

First published 2003-10

Canadian and US Drug Approval Times and Safety Considerations

Nigel SB Rawson, Kenneth I Kaitin

Annals of Pharmacotherapy

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Research article

First published 2013-11

Approvals of Pharmaceutical Drugs in China in the Post–Drug Registration Regulation II Era

Tiantian Zhang, Jianhong Tao, Jun Xu [...]

Therapeutic Innovation & Regulatory Science

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Other

First published 2001-1

Safety Evaluation for New Drug Approval in Korea

Young-Ok Kim, Kwang-Won Ha, Kwang-Sik Choi

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-9

Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs

Frank J. Sasinowski, Erika B. Panico, James E. Valentine

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2024-2

Approval status of essential therapeutic drugs for systemic sclerosis versus that of drugs for rheumatoid arthritis

Ki Won Moon, Soo-Hee Hwang, Jieun Yun [...]

Journal of Scleroderma and Related Disorders

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Research article

First published 2014-5

Comparison of Drug Approvals in Europe Versus the United States

Robert W. Makuch, Ruizhi Shi

Therapeutic Innovation & Regulatory Science

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Research article

First published 2016-11

Comparison of Drug Use Between Clinical Practice and Regulatory Approval

Nanae Tanemura, Yoshiaki Uyama, Kengo Nagashima [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-11

An Overview and Analysis Regarding the Use of Adjudication Methods in EU and US Drug Approvals

Stephanie Krumholz-Bahner, Mimmo Garibbo, Kenneth A. Getz [...]

Therapeutic Innovation & Regulatory Science

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