000			02019nam a2200301Ia 4500
001			133685
003			0000000000
005			20211104015746.0
008			081022s2009 njua b 001 0 eng
020			_a9780470371381
035			_a(AEA)285949ABCBB347329B3B4D7C932E3ECA
035			_a(OCoLC)ocn246886694
035			_a15499340
050			_aKF 3885 _b.W430 2009
100			_aWeinberg, Sandy, _d-1950 _9103759
245		0	_aGuidebook for drug regulatory submissions / _cSandy Weinberg.
260			_aHoboken, NJ : _bWiley, _cc2009.
300			_ax, 379 p. : _bill. _c24 cm.
504			_aIncludes bibliographical references and index.
505			_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.
520			_aOffers written guide for effective submisssion of documents for required regulatory views during drug development. Provides information on ht emost common types of submissions, including: Meeting Requestss, Orphan Drug Applications, Investigatory New Drug Applications, 505(b) NDAs, Abbreviated New Drug Applications and Annual Report. Explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submisssions processs over the near future. A chapter compares the FDA processs to the four other major regulatory environments of Canada, European Union, Japan and Australia.
650			_aDrug approval _zUnited States. _9103760
650			_aDrug Approval _zUnited States. _9103761
650			_aDrugs _zUnited States. _9103762
650			_aDrugs, Investigational _zUnited States. _9103763
942			_cREF
999			_c72300 _d72300