Guidebook for drug regulatory submissions [electronic resource] / Sandy Weinberg.
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 t...
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| Online Access: |
Full Text (via Wiley) |
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| Main Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J. :
John Wiley,
©2009.
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| Subjects: |
| Summary: | 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. |
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| Physical Description: | 1 online resource (x, 379 pages) : illustrations. |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: | 9780470456170 0470456175 |