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010 |a  2013047346 
020 |a 9781841849195 
020 |a 1841849197 
035 |a (OCoLC)864382873 
035 |a .b6380669  |b lst1   |c - 
040 |a DNLM/DLC  |b eng  |e rda  |c DLC  |d YDX  |d NLM  |d YDXCP  |d OCLCO  |d OCLCF  |d OCLCQ  |d UtOrBLW 
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049 |a UCXA 
050 4 |a KF3871  |b .F33 2014 
060 0 0 |a 2014 C-434 
060 1 0 |a QV 771 
082 0 0 |a 615/.19  |2 23 
245 0 0 |a FDA regulatory affairs /  |c edited by David Mantus, Douglas J. Pisano. 
246 3 |a Food and Drug Administration regulatory affairs. 
250 |a Third edition. 
264 1 |a Boca Raton, FL :  |b CRC Press, Taylor & Francis Group,  |c [2014] 
300 |a xii, 387 pages :  |b illustrations, forms ;  |c 24 cm. 
336 |a text  |b txt  |2 rdacontent. 
337 |a unmediated  |b n  |2 rdamedia. 
338 |a volume  |b nc  |2 rdacarrier. 
504 |a Includes bibliographical references and index. 
505 0 |a Overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- What is an IND? / Michael R. Hamrell -- The new drug application / Charles Monahan and Josephine C. Babiarz -- Meetings with the FDA / Alberto Grignolo and Sally Choe -- FDA medical device regulation / Barry Sall -- A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- The development of orphan drugs / Scott N. Freeman -- CMC sections of regulatory filings and CMC regulatory Compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- Overview of the GxPs for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- The practice of regulatory affairs / David S. Mantus -- FDA advisory Committees / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner. 
610 1 0 |a United States.  |b Food and Drug Administration  |v Rules and practice. 
610 1 0 |a United States.  |b Food and Drug Administration. 
650 0 |a Drug development  |z United States. 
650 0 |a Pharmaceutical industry  |z United States. 
650 1 0 |a Drug approval  |z United States. 
650 2 0 |a Biological products  |x Standards  |z United States. 
610 1 7 |a United States.  |b Food and Drug Administration.  |2 fast  |0 (OCoLC)fst00549734. 
650 1 2 |a United States Government Agencies  |z United States. 
650 2 2 |a Equipment and Supplies  |x standards  |z United States. 
650 2 2 |a Government Regulation  |z United States. 
650 7 |a Drug development.  |2 fast  |0 (OCoLC)fst00898670. 
650 7 |a Pharmaceutical industry.  |2 fast  |0 (OCoLC)fst01060129. 
651 7 |a United States.  |2 fast  |0 (OCoLC)fst01204155. 
655 7 |a Rules.  |2 fast  |0 (OCoLC)fst01423857. 
700 1 |a Mantus, David,  |e editor. 
700 1 |a Pisano, Douglas J.,  |e editor. 
902 |a 220722 
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952 f f |p Can circulate  |a University of Colorado Boulder  |b Law Campus  |c Law  |d Law Library - Stacks 1st floor  |e KF3871 .F33 2014  |h Library of Congress classification  |i book  |m U182004804600  |n 1