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) |
|---|---|
| Main Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J. :
John Wiley,
©2009.
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| Subjects: |
MARC
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| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a Ten rules for drug regulatory submissions -- FDA meeting requests -- Orphan-drug applications -- Investigational new drug applications (INDs) -- New drug applications (NDAs) -- 505(b)2 new drug applications (NDAs) -- Abbreviated new drug applications (ANDAs) -- Annual reports -- International submissions / Carl A. Rockburne -- Future issues in regulatory submissions. | |
| 520 | |a 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. | ||
| 588 | 0 | |a Print version record. | |
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