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02788aam a2200385Ii 4500 001 70A94480462211E9A3F20F6897128E48 003 SILO 005 20190314012734 008 181023s2018 enka b 001 0 eng d 020 $a 0128111550 (paperback) 020 $a 9780128111550 (paperback) 035 $a (OCoLC)1011516845 035 $a (OCoLC)1057702761 040 $a LPU $b eng $e rda $c LPU $d YDX $d TXP $d OCLCF $d UKMGB $d SILO 050 4 $a HF5415.153 $b .O84 2018 082 04 $a 658.5/75 $2 23 245 03 $a An overview of FDA regulated products : $b from drugs and cosmetics to food and tobacco / $c edited by Eunjoo Pacifici, Susan Bain. 264 1 $a London : $b Academic Press, an imprint of Elsevier, $c [2018] 300 $a xxi, 268 pages : $b illustrations ; $c 23 cm 504 $a Includes bibliographical references and index. 520 $a Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. 610 10 $a United States. $b Food and Drug Administration. 610 17 $a United States. $b Food and Drug Administration. $2 fast $0 (OCoLC)fst00549734 650 0 $a Food law and legislation $z United States. 650 0 $a Drugs $x Law and legislation $z United States. 650 7 $a Manufactures. $2 fast $0 (OCoLC)fst01007993 650 7 $a New products. $2 fast $0 (OCoLC)fst01036889 651 7 $a United States. $2 fast $0 (OCoLC)fst01204155 700 1 $a Pacifici, Eunjoo, $e editor. 700 1 $a Bain, Susan, editor. 776 08 $i ebook version : $z 9780128111567 941 $a 2 952 $l OVUX522 $d 20231019012107.0 952 $l USUX851 $d 20230405012021.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=70A94480462211E9A3F20F6897128E48Initiate Another SILO Locator Search