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Articles (305)

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1-10 of 305 results for approved products and in clinical development

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Select article: Development of Drug-Approval Regulations for Medical Countermeasures Against CBRN Agents in Japan

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Research article

First published 2015-04

Development of Drug-Approval Regulations for Medical Countermeasures Against CBRN Agents in Japan

Rumiko Shimazawa, Masayuki Ikeda

Health Security

Select article: Regulatory Challenges for Cartilage Repair Technologies

Free access

Research article

First published 2013-1

Regulatory Challenges for Cartilage Repair Technologies

Kevin B. McGowan, Glenn Stiegman

CARTILAGE

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: Innovative medicine development

Free access

Other

First published 2022-3

Innovative medicine development

Valerie Pimpaneau, Emmanuelle Voisin

Technology and Health Care

Select article: Clinical Development of Biologics Approved by the US Food and Drug Administration,2003-2016

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Research article

First published 2019-11

Clinical Development of Biologics Approved by the US Food and Drug Administration,2003-2016

G. Caleb Alexander, Ken Ogasawara, Dana Wiegand [...]

Therapeutic Innovation & Regulatory Science

Select article: Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration,2010-2015

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Research article

First published 2017-1

Analysis of Fixed-Dose Combination Products Approved by the US Food and Drug Administration,2010-2015

Kyu Chan Kwon, Chulung Lee

Therapeutic Innovation & Regulatory Science

Select article: Regulation Policy on Cell- and Tissue-Based Therapy Products in Korea

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Research article

First published 2015-12

Regulation Policy on Cell- and Tissue-Based Therapy Products in Korea

Jeong Ok Lim

Tissue Engineering Part A: Research Advances

Select article: The Role of the Food and Drug Administration in Pharmacoeconomic Evaluation during the Drug Development Process *

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Other

First published 2000-10

The Role of the Food and Drug Administration in Pharmacoeconomic Evaluation during the Drug Development Process *

Jennifer Kim, Carolyn Blank Morris, Kevin Alan Schulman

Therapeutic Innovation & Regulatory Science

Select article: The Translation of Product Concept to Bone Products: A Partnership of Therapeutic Effectiveness and Commercialization

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Review article

First published 2011-12

The Translation of Product Concept to Bone Products: A Partnership of Therapeutic Effectiveness and Commercialization

Anthony Ratcliffe

Tissue Engineering Part B: Reviews

Select article: Vioxx and other pharmaceutical product withdrawals: ethical issues in ensuring the integrity of drug and medical device research,development and commercialization

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Research article

First published 2007-09

Vioxx and other pharmaceutical product withdrawals: ethical issues in ensuring the integrity of drug and medical device research,development and commercialization

Clinical Ethics

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