Drug Development & Rare Pediatric Diseases

Drug Development & Rare Pediatric Diseases

Sale price  £59.24 Regular price  £78.99
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Drug Development & Rare Pediatric Diseases

Drug Development & Rare Pediatric Diseases

Issues, Strategic Plan, & Voucher Program Assessment

Written by Frederick Johnston

Sale price  £59.24 Regular price  £78.99
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Over the past few decades, a number of legislative actions have been taken to encourage the development of therapies to treat people affected by rare diseases and to encourage therapies for pediatric patients. During this same time period, the Food and Drug Administration (FDA) has invested substantial effort in support of these same goals. As described in this book, recent legislative actions have prompted new initiatives. Continuing the response to the laws specific requirements and FDAs commitment under PDUFA, this book includes input from the public and FDA and discusses the many complex issues involved in medical product development for people with rare diseases. Following a brief overview of both legislative and FDA efforts over the years to foster development of therapies for these patients, the book summarizes the three days of the public meeting and presents FDAs strategic plan for accelerating the development of the urgently needed therapies for pediatric rare diseases.
ISBN-13
9781536102277
Publication date
1 December 2016
Format
Paperback
Pages
122
Dimensions
230 x 155 mm
Language
English

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