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• 001 0000410456

• 003 SCNU

• 005 20111216091435.0

• 008 081022s2009 njua b 001 0 eng

• 010 __ |a 2008044679

• 020 __ |a 9780470371381 (cloth)

• 035 __ |a (OCoLC)246886694

• 040 __ |a DNLM/DLC |c DLC |d YDX |d NLM |d BTCTA |d YDXCP

• 043 __ |a n-us---

• 050 00 |a KF3885 |b .W45 2009

• 082 00 |a 344.7304/233 |2 22

• 093 __ |a D971.221 |2 4

• 099 __ |a CAL 022009161976

• 100 1_ |a Weinberg, Sandy, |d 1950-

• 245 10 |a Guidebook for drug regulatory submissions / |c Sandy Weinberg.

• 260 __ |a Hoboken, N.J. : |b John Wiley, |c c2009.

• 300 __ |a x, 379 p. : |b ill. ; |c 25 cm.

• 504 __ |a Includes bibliographical references and index.

• 505 0_ |a 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.

• 650 _0 |a Drugs |x Law and legislation |z United States.

• 650 _0 |a Drug approval |z United States.

• 950 __ |a SCNU |f D971.221/W423

• 999 __ |t E |A zxq |a 20111216 09:13:55 |G zxq |g 20111216 09:13:24 |M zxq |m 20111216 09:27:48

• 000 1000024269

• 991 __ |a 022011000504

• 907 __ |a SCNU |f D971.221/W423