000			01829nam a2200181Ia 4500
008			140223b2008 xxu||||| |||| 00| 0 eng d
020			_a9781420073546 _c0.00
082			_a343.0761 _bFDA
245			_aFDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices and Biologics
250			_a2nd ed
260			_aNew York _bInforma Healthcare USA, Inc. _c2008
300			_a448p
500			_aExamines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval. regulatory professional, electronic submissions, medical device regulation, orphan drug regulations, regulatory affairs, quality systems approach, applicability statement, clinical safety data management, user fee cover sheet, device name, success criteria, medical device clinical research, biologic trials, draft guidance titled, medically plausible subset, violative materials, common bookmarks, advisory committee system, design control provisions, electronic regulatory submissions, orphan designation, designation request, prevalence threshold, medical device studies, clinical hold
700			_aPisano, Douglas J. _eEditor _9108461
700			_aMantus, David S. _eEditor _9108462
942			_2ddc _cLB
995			_aPharmacy Reference _eP0006725 _j615.19 _yP0006725
999			_c15519 _d15519