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Book Details
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.
Classifications
The Physical Object
ID Numbers
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- Created December 11, 2008
- 15 revisions
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December 31, 2022 | Edited by MARC Bot | import existing book |
November 15, 2022 | Edited by ImportBot | import existing book |
October 4, 2021 | Edited by ImportBot | import existing book |
December 20, 2020 | Edited by MARC Bot | import existing book |
December 11, 2008 | Created by ImportBot | Imported from Library of Congress MARC record |