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Guidebook for drug regulatory submissions

Author: Sandy Weinberg
Publisher: Hoboken, N.J. : John Wiley, ©2009.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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,  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
Weinberg, Sandy, 1950-
Guidebook for drug regulatory submissions.
Hoboken, N.J. : John Wiley, ©2009
(DLC) 2008044679
(OCoLC)246886694
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Sandy Weinberg
ISBN: 9780470456170 0470456175
OCLC Number: 320541114
Description: 1 online resource (x, 379 pages) : illustrations
Contents: 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.
Responsibility: Sandy Weinberg.

Abstract:

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  Read more...

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"The Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development." ( Read more...

 
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