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FDA regulatory affairs :a guide for prescription drugs, medical devices, and biologics /
正題名/作者 ： FDA regulatory affairs :/ edited by Douglas J. Pisano, David S. Mantus.
其他題名 ： a guide for prescription drugs, medical devices, and biologics /
其他作者 ： Pisano, Douglas J.
出版者 ： New York ;Informa Healthcare,c2008.
面頁冊數 ： viii, 448 p. :ill. ;24 cm.
標題 ： Drug development - United States. -
電子資源 ： 電子資源
ISBN ： 9781420073546 (hbk.)
ISBN ： 1420073540 (hbk.)
LEADER 01916cam 2200241 a 450
001 184521
003 DLC
005 20090831122046.0
008 080327s2008 nyua b 001 0 eng
010 $a2008014296
020 $a9781420073546 (hbk.)
020 $a1420073540 (hbk.)
035 $a00222341
050 4$aRM301.25$b.F37 2008
082 04$a615/.19$222
090 $a615.19/F299/2008///UM044978
245 00$aFDA regulatory affairs :$ba guide for prescription drugs, medical devices, and biologics /$cedited by Douglas J. Pisano, David S. Mantus.
250 $a2nd ed.
260 $aNew York ;$aLondon :$bInforma Healthcare,$cc2008.
300 $aviii, 448 p. :$bill. ;$c24 cm.
504 $aIncludes bibliographical references and index.
505 0 $aOverview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vah歋 Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer.
610 10$aUnited States.$bFood and Drug Administration$vRules and practice.$3330167
610 12$aUnited States.$bFood and Drug Administration.$3260692
650 0$aDrug development$zUnited States.$3330170
650 0$aPharmaceutical industry$zUnited States.$3260072
650 12$aDrug Industry$xstandards$zUnited States.$3330171
650 12$aUnited States Government Agencies$zUnited States.$3330172
650 22$aBiological Products$xstandards$zUnited States.$3330173
650 22$aEquipment and Supplies$xstandards$zUnited States.$3330174
650 22$aGovernment Regulation$zUnited States.$3266426
700 1 $aPisano, Douglas J.$3330168
700 1 $aMantus, David.$3330169
856 $uhttp://www.loc.gov/catdir/enhancements/fy0829/2008014296-d.html$z電子資源
856 $uhttp://www.loc.gov/catdir/toc/ecip0814/2008014296.html$z電子資源
FDA regulatory affairs :a guide for prescription drugs, medical devices, and biologics /edited by Douglas J. Pisano, David S. Mantus. - 2nd ed. - New York ;Informa Healthcare,c2008. - viii, 448 p. :ill. ;24 cm.
Includes bibliographical references and index.
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 Vah歋 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.
ISBN: 9781420073546 (hbk.)
LCCN: 2008014296Subjects--Corporate Names:
330167
United States.
Food and Drug Administration--Rules and practice.Subjects--Topical Terms:
330170
Drug development
--United States.
LC Class. No.: RM301.25 / .F37 2008
Dewey Class. No.: 615/.19
Includes bibliographical references and index.
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 Vah歋 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.
ISBN: 9781420073546 (hbk.)
LCCN: 2008014296Subjects--Corporate Names:
330167
United States.
Food and Drug Administration--Rules and practice.Subjects--Topical Terms:
330170
Drug development
--United States.
LC Class. No.: RM301.25 / .F37 2008
Dewey Class. No.: 615/.19
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