Guidebook for drug regulatory submissions / Sandy Weinberg.
Material type:
TextPublication details: Hoboken, NJ : Wiley, c2009.Description: x, 379 p. : ill. 24 cmISBN: - 9780470371381
- KF 3885 .W430 2009
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Reference
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Aklatang Emilio Aguinaldo-Information Resource Center Reference | KF 3885 .W430 2009 (Browse shelf(Opens below)) | Not for loan | 3AEA0000309709 |
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Includes bibliographical references and index.
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.
Offers written guide for effective submisssion of documents for required regulatory views during drug development. Provides information on ht emost common types of submissions, including: Meeting Requestss, Orphan Drug Applications, Investigatory New Drug Applications, 505(b) NDAs, Abbreviated New Drug Applications and Annual Report. Explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submisssions processs over the near future. A chapter compares the FDA processs to the four other major regulatory environments of Canada, European Union, Japan and Australia.
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