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Regulatory Aspects of Gene Therapy and Cell Therapy Products
Language: en
Pages: 235
Authors: Maria Cristina Galli
Categories: Medical
Type: BOOK - Published: 2015-09-15 - Publisher: Springer

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This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international b
Rare Diseases and Orphan Products
Language: en
Pages: 442
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2011-04-03 - Publisher: National Academies Press

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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions i
Regulation of Biological Products
Language: en
Pages: 40
Authors: National Institutes of Health (U.S.). Division of Biologics Standard
Categories: Biological products
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FDA Investigations Operations Manual
Language: en
Pages: 0
Authors: Food and Drug Administration
Categories: Drugs
Type: BOOK - Published: 2003 - Publisher:

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Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the go
Medical Device Regulations
Language: en
Pages: 54
Authors: Michael Cheng
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Type: BOOK - Published: 2003-09-16 - Publisher: World Health Organization

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The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health