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- 2008044679 contributor B11124901.
- 2008044679 created "c2009.".
- 2008044679 date "2009".
- 2008044679 date "c2009.".
- 2008044679 dateCopyrighted "c2009.".
- 2008044679 description "Includes bibliographical references and index.".
- 2008044679 description "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.".
- 2008044679 extent "x, 379 p. :".
- 2008044679 identifier "0470371382 (hbk.)".
- 2008044679 identifier "9780470371381 (hbk.)".
- 2008044679 issued "2009".
- 2008044679 issued "c2009.".
- 2008044679 language "eng".
- 2008044679 publisher "Hoboken, N.J. : Wiley,".
- 2008044679 spatial "United States.".
- 2008044679 subject "2009 D-853".
- 2008044679 subject "344.7304/233 22".
- 2008044679 subject "Drug Approval United States.".
- 2008044679 subject "Drug approval United States.".
- 2008044679 subject "Drugs Law and legislation United States.".
- 2008044679 subject "Drugs, Investigational United States.".
- 2008044679 subject "KF3885 .W45 2009".
- 2008044679 subject "QV 771 W423g 2009".
- 2008044679 tableOfContents "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.".
- 2008044679 title "Guidebook for drug regulatory submissions / Sandy Weinberg.".
- 2008044679 type "text".