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Orphan Drugs
A Guide for Bringing New Medicines to Those in Need
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Main description:

This book is a "how to" book that shows people with ideas how to meet the scientific, financial, and regulatory challenges of orphan drug development. Written by the Director of FDA′s Office of Orphan Products Development with contributing authors both inside and outside government, this book relates the history of the 1983 Orphan Drug Act and the 1,955 orphan–designated drugs it has spawned, some 334 of which have received marketing approval for the treatment of rare diseases. As such, it offers an insider′s view of drug development from thought to therapy.


PRODUCT DETAILS

ISBN-13: 9780470551332
Publisher: John Wiley & Sons Ltd (Wiley–Blackwell)
Publication date: March, 2018
Pages: 352
Weight: 652g
Availability: Not available (reason unspecified)
Subcategories: Diseases and Disorders, Public Health

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