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Guide to EU and UK Pharmaceutical Regulatory Law
Language: en
Pages: 840
Authors: Sally Shorthose
Categories: Law
Type: BOOK - Published: 2023-01-10 - Publisher: Kluwer Law International B.V.

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In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more
Navigating European Pharmaceutical Law
Language: en
Pages: 0
Authors: Maria Isabel Manley
Categories: Law
Type: BOOK - Published: 2015 - Publisher: Oxford University Press, USA

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Patents / Dominic Adair, Greg Bacon, and Vanessa Rieu -- Clinical trials / Helen Middleton -- Procedures for obtaining a marketing authorisation and legal bases
Guide to EU Pharmaceutical Regulatory Law
Language: en
Pages: 590
Authors: Sally Shorthose
Categories: Law
Type: BOOK - Published: 2017-02-17 - Publisher: Kluwer Law International B.V.

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In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislatio
Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022
Language: en
Pages: 1140
Authors: Medicines and Healthcare Products Regulatory Agency
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Type: BOOK - Published: 2022-03-07 - Publisher:

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Medical Devices and the Public's Health
Language: en
Pages: 318
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2011-11-25 - Publisher: National Academies Press

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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In