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02682cam a22004214a 4500 001 79EA5DF46BFD11DEA13FF332A8D7520A 003 SILO 005 20090730152105 008 080327s2008 nyua b 001 0 eng 010 $a 2008014296 020 $a 1420073540 (hbk. : alk. paper) 020 $a 9781420073546 (hbk. : alk. paper) 040 $a DNLM/DLC $c DLC $d SILO $d YDXCP $d BAKER $d BTCTA $d C#P $d CDX $d BWX $d IWO $d SILO 042 $a pcc 043 $a n-us--- 050 00 $a RM301.25 $b .F37 2008 082 00 $a 615/.19 $2 22 245 0 $a FDA regulatory affairs : $b a guide for prescription drugs, medical devices, and biologics / $c edited by Douglas J. Pisano, David S. Mantus. 250 $a 2nd ed. 260 $a New York : $b Informa Healthcare USA, $c c2008. 300 $a viii, 448 p. : $b ill. ; $c 24 cm. 504 $a Includes bibliographical references and index. 505 0 $a Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and VaheÌ Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer. 650 0 $a Drug development $z United States. 610 10 $a United States. $b Food and Drug Administration $v Rules and practice. 650 0 $a Pharmaceutical industry $z United States. 610 12 $a United States. $b Food and Drug Administration. 650 12 $a Drug Approval $z United States. 650 12 $a United States Government Agencies $z United States. 650 22 $a Biological Products $x standards $z United States. 650 22 $a Equipment and Supplies $x standards $z United States. 650 22 $a Government Regulation $z United States. 700 1 $a Pisano, Douglas J. 700 1 $a Mantus, David. 941 $a 1 952 $l OVUX522 $d 20180106064942.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=79EA5DF46BFD11DEA13FF332A8D7520A 994 $a 02 $b IWOInitiate Another SILO Locator Search