01442nam\a2200301\a\4500 57853 20260628152406.0 260628s2009 njua b 001 0 eng 9780470371381 hbk. 0470371382 hbk. DNLM/DLC DLC YDX NLM BTCTA YDXCP CDX BWX IXA BD-DhIUB 344.7304233 22 W4231g Weinberg, Sandy, 1950- Guidebook for drug regulatory submissions / Sandy Weinberg. Hoboken, N.J. : Wiley, c2009. x, 379 p. : ill. ; 25 cm. 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. PHR phr PHAR Karim Drugs Law and legislation United States. Drug approval United States. Drug Approval United States. Drugs, Investigational United States. ddc BK 57853 58027 0 0 ddc 0 1 IUBL IUBL PHAR 2026-06-21 PURCHASE 9690.00 2009 0 344.7304233 W4231g 029831 2026-06-28 15:26:25 01 19380.00 2026-06-21 BK