MARC状态:已编 文献类型:西文图书 浏览次数:70
- 题名/责任者:
- Guidebook for drug regulatory submissions / Sandy Weinberg.
- 出版发行项:
- Hoboken, N.J. : John Wiley, c2009.
- ISBN:
- 9780470371381 (cloth)
- 载体形态项:
- x, 379 p. : ill. ; 25 cm.
- 个人责任者:
- Weinberg, Sandy, 1950-
- 论题主题:
- Drugs-Law and legislation-United States.
- 论题主题:
- Drug approval-United States.
- 中图法分类号:
- D971.221
- 书目附注:
- Includes bibliographical references and index.
- 内容附注:
- 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.
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