Guidebook for drug regulatory submissions:
Saved in:
| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J.
John Wiley
©2009
|
| Subjects: | |
| Online Access: | FRO01 UBG01 Volltext |
| Item Description: | Includes bibliographical references and index 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 |
| Physical Description: | 1 Online-Ressource (x, 379 pages) |
| ISBN: | 9780470456170 0470456175 9780470456187 0470456183 |
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| 100 | 1 | |a Weinberg, Sandy |e Verfasser |4 aut | |
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| 500 | |a Includes bibliographical references and index | ||
| 500 | |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 | ||
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| id | DE-604.BV043389548 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:24:37Z |
| institution | BVB |
| isbn | 9780470456170 0470456175 9780470456187 0470456183 |
| language | English |
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| physical | 1 Online-Ressource (x, 379 pages) |
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| publishDate | 2009 |
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| spelling | Weinberg, Sandy Verfasser aut Guidebook for drug regulatory submissions Sandy Weinberg Hoboken, N.J. John Wiley ©2009 1 Online-Ressource (x, 379 pages) txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references and index 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 Drug Approval / United States Drugs, Investigational / United States Drug approval Drugs, Investigational Drugs LAW / Administrative Law & Regulatory Practice bisacsh Drug approval fast Drugs / Law and legislation fast Recht Drugs / Law and legislation / United States Drug approval / United States United States fast USA Erscheint auch als Druck-Ausgabe, Hardcover 978-0-470-37138-1 Erscheint auch als Druck-Ausgabe, Hardcover 0-470-37138-2 https://onlinelibrary.wiley.com/doi/book/10.1002/9780470456187 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Weinberg, Sandy Guidebook for drug regulatory submissions Drug Approval / United States Drugs, Investigational / United States Drug approval Drugs, Investigational Drugs LAW / Administrative Law & Regulatory Practice bisacsh Drug approval fast Drugs / Law and legislation fast Recht Drugs / Law and legislation / United States Drug approval / United States |
| title | Guidebook for drug regulatory submissions |
| title_auth | Guidebook for drug regulatory submissions |
| title_exact_search | Guidebook for drug regulatory submissions |
| title_full | Guidebook for drug regulatory submissions Sandy Weinberg |
| title_fullStr | Guidebook for drug regulatory submissions Sandy Weinberg |
| title_full_unstemmed | Guidebook for drug regulatory submissions Sandy Weinberg |
| title_short | Guidebook for drug regulatory submissions |
| title_sort | guidebook for drug regulatory submissions |
| topic | Drug Approval / United States Drugs, Investigational / United States Drug approval Drugs, Investigational Drugs LAW / Administrative Law & Regulatory Practice bisacsh Drug approval fast Drugs / Law and legislation fast Recht Drugs / Law and legislation / United States Drug approval / United States |
| topic_facet | Drug Approval / United States Drugs, Investigational / United States Drug approval Drugs, Investigational Drugs LAW / Administrative Law & Regulatory Practice Drugs / Law and legislation Recht Drugs / Law and legislation / United States Drug approval / United States United States USA |
| url | https://onlinelibrary.wiley.com/doi/book/10.1002/9780470456187 |
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