An edition of Guidebook for drug regulatory submissions
(2009)
Guidebook for drug regulatory submissions
by Sandy Weinberg
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Book Details
Published in
Hoboken, N.J
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.
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| October 4, 2021 | Edited by ImportBot | import existing book |
| December 20, 2020 | Edited by MARC Bot | import existing book |
| 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. |