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December 28, 2011 | History

Guidebook for drug regulatory submissions 1 edition

Guidebook for drug regulatory submissions
Sandy Weinberg

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Guidebook for drug regulatory submissions
Sandy Weinberg.

Published 2009 by John Wiley in Hoboken, N.J .
Written in English.

Table of Contents

Rules for drug regulatory submissions
FDA meeting requests
Orphan drug applications
Investigatory new drug applications (INDS)
New drug applications (NDAS)
505(b)2 new drug applications
Abbreviated new drug applications (ANDAS)
Annual reports
International submissions / by Carl A. Rockburne
Future issues in regulatory submissions.

Edition Notes

Includes bibliographical references and index.


Dewey Decimal Class
Library of Congress
KF3885 W45 2009

The Physical Object

p. cm.

ID Numbers

Open Library
Internet Archive
LC Control Number
Library Thing

History Created December 11, 2009 · 5 revisions Download catalog record: RDF / JSON

December 28, 2011 Edited by LC Bot import new book
December 28, 2011 Edited by LC Bot import new book
December 4, 2010 Edited by Open Library Bot Added subjects from MARC records.
January 29, 2010 Edited by WorkBot add more information to works
December 11, 2009 Created by WorkBot add works page