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FDA regulatory affairs

Record Type:	Language materials, printed : Monograph/item
Title/Author:	FDA regulatory affairs/ edited by David Mantus, Douglas J. Pisano.
other author:	Mantus, David,
Published:	Boca Raton, FL :CRC Press, : 2014.,
Description:	1 online resource (xii, 387 p.)
Subject:	Drug development - United States. -
Online resource:	http://www.crcnetbase.com/isbn/9781841849201
Online resource:	https://www.taylorfrancis.com/books/9780429186202
ISBN:	9781841849201

FDA regulatory affairs
FDA regulatory affairs[electronic resource] /edited by David Mantus, Douglas J. Pisano. - 3rd ed. - Boca Raton, FL :CRC Press,2014. - 1 online resource (xii, 387 p.)

Includes bibliographical references and index.

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.

ISBN: 9781841849201Subjects--Corporate Names:

798640
United States.
Food and Drug Administration--Rules and practice.Subjects--Topical Terms:

583248
Drug development
--United States.

LC Class. No.: RM301.25 / .F37 2014

Dewey Class. No.: 615/.19

National Library of Medicine Call No.: QV 771

FDA regulatory affairs
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020 $a 9781841849201 $q (electronic bk.)
020 $a 1841849200 $q (electronic bk.)
020 $z 9781841849195 $q (hardcover : $q alk. paper)
020 $z 1841849197 $q (hardcover : $q alk. paper)
035 $a (OCoLC)872703723 $z (OCoLC)869639807
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040 $a CNSPO $b eng $c CNSPO $d OCLCO $d OCLCF $d OCLCO $d AZU $d YDXCP $d OCLCA $d UIU $d CRCPR $d OCLCQ $d EBLCP $d E7B
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050 4 $a RM301.25 $b .F37 2014
060 4 $a QV 771
082 0 4 $a 615/.19 $2 23
245 0 0 $a FDA regulatory affairs $h [electronic resource] / $c edited by David Mantus, Douglas J. Pisano.
250 $a 3rd ed.
260 $a Boca Raton, FL : $b CRC Press, $c 2014.
300 $a 1 online resource (xii, 387 p.)
504 $a Includes bibliographical references and index.
520 $a FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.
588 0 $a Print version record.
610 1 0 $a United States. $b Food and Drug Administration $v Rules and practice. $3 798640
610 1 2 $a United States. $b Food and Drug Administration. $3 798609
650 0 $a Drug development $z United States. $3 583248
650 0 $a Pharmaceutical industry $z United States. $3 583249
650 1 2 $a Drug Approval $z United States. $3 583483
650 1 2 $a United States Government Agencies $z United States. $3 635761
650 2 2 $a Biological Products $x standards $z United States. $3 582871
650 2 2 $a Equipment and Supplies $x standards $z United States. $3 582872
650 2 2 $a Government Regulation $z United States. $3 778454
700 1 $a Mantus, David, $3 1060817
700 1 $a Pisano, Douglas J. $3 570573
856 4 0 $u http://www.crcnetbase.com/isbn/9781841849201
856 4 0 $u https://www.taylorfrancis.com/books/9780429186202