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FDA regulatory affairs

Pisano, Douglas J.

FDA regulatory affairs

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	FDA regulatory affairs/ edited by David Mantus, Douglas J. Pisano.
其他作者:	Pisano, Douglas J.
出版者:	Boca Raton, FL :CRC Press, : 2014.,
版本:	3rd ed.
面頁冊數:	1 online resource (xii, 387 p.)
提要註:	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.
標題:	Government Regulation - United States. -
電子資源:	http://www.crcnetbase.com/isbn/9781841849201
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:

253556
United States.
Food and Drug Administration.Subjects--Topical Terms:

335789
Government Regulation
--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.)
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020 $z 1841849197 $q (hardcover : $q alk. paper)
035 $a (OCoLC)872703723 $z (OCoLC)869639807
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050 4 $a RM301.25 $b .F37 2014
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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 : $c 2014. $b CRC Press,
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 2 $a United States. $b Food and Drug Administration. $3 253556
610 1 0 $a United States. $b Food and Drug Administration $v Rules and practice. $3 382242
650 2 2 $a Government Regulation $z United States. $3 335789
650 2 2 $a Equipment and Supplies $x standards $z United States. $3 322784
650 2 2 $a Biological Products $x standards $z United States. $3 382247
650 1 2 $a United States Government Agencies $z United States. $3 382246
650 1 2 $2 96060 $a Drug Approval $z United States. $3 267256
650 0 $2 96060 $a Pharmaceutical industry $z United States. $3 219334
650 0 $a Drug development $z United States. $3 382245
700 1 $a Pisano, Douglas J. $3 382244
700 1 $a Mantus, David, $3 382243
856 4 0 $u http://www.crcnetbase.com/isbn/9781841849201

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