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FDA regulatory affairs

Mantus, David,

FDA regulatory affairs

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	FDA regulatory affairsedited 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 developmentUnited States.
電子資源:	http://www.crcnetbase.com/isbn/9781841849201
ISBN:	9781841849201$q(electronic bk.)

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: 9781841849201$q(electronic bk.)Subjects--Corporate Names:

444538
United States.
Food and Drug Administration--Rules and practice.Subjects--Topical Terms:

302732
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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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.
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650 2 2 $a Government Regulation $z United States. $3 520452
700 1 $a Mantus, David, $3 716746
700 1 $a Pisano, Douglas J. $3 298008
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