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FDA regulatory affairs

United States., Food and Drug Administration

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FDA regulatory affairs

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	FDA regulatory affairs/ edited by David Mantus, Douglas J. Pisano.
其他作者:	Mantus, David,
出版者:	Boca Raton, FL :CRC Press, : 2014.,
面頁冊數:	1 online resource (xii, 387 p.)
標題:	Drug development - 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:

2123237
United States.
Food and Drug Administration--Rules and practice.Subjects--Topical Terms:

916415
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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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.
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650 1 2 $a United States Government Agencies $z United States. $3 1009136
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650 2 2 $a Equipment and Supplies $x standards $z United States. $3 916153
650 2 2 $a Government Regulation $z United States. $3 746831
700 1 $a Mantus, David, $3 2142001
700 1 $a Pisano, Douglas J. $3 916413
856 4 0 $u http://www.crcnetbase.com/isbn/9781841849201