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Weinberg, Sandy

Guidebook for Drug Regulatory Submissions

Weinberg, Sandy - Guidebook for Drug Regulatory Submissions, ebook

101,10€

Ebook, PDF with Adobe DRM
ISBN: 9780470456170
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Printing106 pages with an additional page accrued every 7 hours, capped at 106 pages
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The high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the inexperienced regulatory professional charged with preparing a major regulatory submission. This book provides regulatory professionals with the key tools necessary to submit major documents to the United States Food and Drug Administration. The book consists of thirteen chapters, including an introductory and conclusion chapter and 11 units, each consisting of an introductory essay, submission checklist, evaluation checklist giving guidance on FDA criteria, and copies of relevant FDA documents.

Keywords: FDA, Food and Drug Administration, FDA documents, drug development, drug research, pharmaceuticals

Author(s)
Publisher
John Wiley and Sons, Inc.
Publication year
2009
Language
en
Edition
1
Page amount
352 pages
Category
Medicine, Health Care, Mode
Format
Ebook
eISBN (PDF)
9780470456170

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