000			03051cam a2200349 a 4500
999			_c12733 _d12733
001			13833863
005			20210302132710.0
008			050107s2005 nyua b 001 0 eng d
010			_a 2005041971
020			_a0824754646 (alk. paper)
040			_aEG-NcFUE _cEG-NcFUE _erda
043			_an-us---
050	0	0	_aKF2036.D7 _bP47 2005
082	0	0	_222 _a344.7304233 _bP
245	0	4	_aThe pharmaceutical regulatory process / _cedited by Ira R. Berry.
264		1	_aNew York : _bMarcel Dekker, _c2005.
300			_axiii, 711 pages : _billustrations ; _c25 cm.
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
504			_aIncludes bibliographical references and index.
505	0		_aPharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act. New Drug Approval Process: Before and After 1962. FDA Regulation of Biological Products. Generic Drug Approval Process: Pre-1984 History Concerning Generic Drugs. Generic Drug Approval Process: Post 1984: Waxman-Hatch Reform. Food and Drug Administration Modernization Act. FDA's Antibiotic Regulatory Scheme: Then and Now. Pioneer and Generic Drugs: Balance Between Product Life Cycle Extension and Anti-Competitive Behavior. The Influence of the Prescription Drug User Fee Act on the Approval Process. Clinical Research Requirements for New Drug Applications. Active Pharmaceutical Ingredients. Obtaining Approval of a New Drug . Obtaining Approval of a Generic Drug. Current Good Manufacturing Practice and the Drug Approval Process. CMC Post-Approval Regulatory Affairs: Constantly Managing Change. The Influence of the USP on the Drug Approval Process. Ways and Means to U.S. Registration of Foreign Drugs. Common Technical Document-Quality (M4-Q): One Regulatory Participant's Perspective. 21 CFR Part 11: Compliance and Beyond. Marketing and Advertising Promotion: The Impact of Government Regulations. Approval and Marketing of Nonprescription or OTC Human Drugs.
520			_a"Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States - standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality issues influencing the pharmaceutical industry."--book jacket.
650		0	_aPharmacy _xLaw and legislation _zUnited States.
650		0	_aDrugs _xLaw and legislation _zUnited States.
700	1		_aBerry, Ira R., _d1942- _eauthor
856	4	2	_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0647/2005041971-d.html
906			_a7 _bcbc _corignew _d1 _eocip _f20 _gy-gencatlg
942			_2ddc _cBK