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Online Public Access Catalogue

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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