000			01442nam\a2200301\a\4500
001			57853
005			20260628152406.0
008			260628s2009 njua b 001 0 eng
020			_a9780470371381 _qhbk.
020			_a0470371382 _qhbk.
040			_aDNLM/DLC _cDLC _dYDX _dNLM _dBTCTA _dYDXCP _dCDX _dBWX _dIXA _dBD-DhIUB
082	0	0	_a344.7304233 _222 _bW4231g
100	1		_aWeinberg, Sandy, _d1950-
245	1	0	_aGuidebook for drug regulatory submissions / _cSandy Weinberg.
260			_aHoboken, N.J. : _bWiley, _cc2009.
300			_ax, 379 p. : _bill. ; _c25 cm.
504			_aIncludes bibliographical references and index.
505	0		_aTen 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.
526			_aPHR _bphr _lPHAR
541			_aKarim
650		0	_aDrugs _xLaw and legislation _zUnited States.
650		0	_aDrug approval _zUnited States.
650	1	2	_aDrug Approval _zUnited States.
650	2	2	_aDrugs, Investigational _zUnited States.
942			_2ddc _cBK
999			_c57853 _d58027