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Articles (12)

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1-10 of 12 results for EMEA regulation

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Select article: Ensuring Better Medicine for Children in Europe: Overview of the European Paediatric Medicines Regulation EC 1901/2006 and Role of the EMEA

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First published 2009-3

Ensuring Better Medicine for Children in Europe: Overview of the European Paediatric Medicines Regulation EC 1901/2006 and Role of the EMEA

Therapeutic Innovation & Regulatory Science

Select article: PIDs in the EU: A regulator's perspective of intravenous immunoglobulins (IVIGs)

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Research article

First published 2008-2

PIDs in the EU: A regulator's perspective of intravenous immunoglobulins (IVIGs)

Jacqueline Kerr

Pharmaceuticals Policy and Law

Select article: Assessing the Performance of the EMEA's Centralized Procedure: A Comparative Analysis with the US FDA

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First published 2008-1

Assessing the Performance of the EMEA's Centralized Procedure: A Comparative Analysis with the US FDA

Laura B. Faden, Kenneth I. Kaitin

Therapeutic Innovation & Regulatory Science

Select article: Coping with the Regulatory Realities of Follow-on Biologics and the Nuances of US and European Regulations

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First published 2010-3

Coping with the Regulatory Realities of Follow-on Biologics and the Nuances of US and European Regulations

Joel I. Folk, Ross A. Davidson

Therapeutic Innovation & Regulatory Science

Select article: Orphan medicinal products – The role of the EMEA

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Research article

First published 2001-2

Orphan medicinal products – The role of the EMEA

Patrick Le Courtois, Melanie Carr

Pharmaceuticals Policy and Law

Select article: The United States Food and Drugs Administration Approves a Generic Enoxaparin

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Editorial

First published 2011-2

The United States Food and Drugs Administration Approves a Generic Enoxaparin

Frederick A. Ofosu

Clinical and Applied Thrombosis/Hemostasis

Select article: New Incentives for SMEs: Life Made Easier for Small Manufacturers in Europe

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Research article

First published 2006-4

New Incentives for SMEs: Life Made Easier for Small Manufacturers in Europe

Nicolas Rossignol

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Select article: Clinical trials for paediatric medicines in Europe

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Research article

First published 2009-2

Clinical trials for paediatric medicines in Europe

P. Baiardi, S. Girotto, O. Della Pasqua [...]

Pharmaceuticals Policy and Law

Select article: Recommendations for drug development for children

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Research article

First published 2009-2

Recommendations for drug development for children

M. Catapano, C. Manfredi, P. Paolucci [...]

Pharmaceuticals Policy and Law

Select article: Clinical Trial Disclosure: Global Overview and Implications of New Laws and Guidelines

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First published 2010-5

Clinical Trial Disclosure: Global Overview and Implications of New Laws and Guidelines

Kathy B. Thomas, Merete Joergensen, Gerard Lynch [...]

Therapeutic Innovation & Regulatory Science

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