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FDA regulatory affairs

紀錄類型:	書目-電子資源 : 單行本
其他作者:	MantusDavid,
其他作者:	PisanoDouglas J.,
出版地:	Boca Raton, FL
出版者:	CRC Press;
出版年:	2014.
版本:	3rd ed.
面頁冊數:	1 online resource (xii, 387 p.)
標題:	Drug development - United States -
標題:	Pharmaceutical industry - United States -
標題:	Drug Approval - United States -
標題:	United States Government Agencies - United States -
標題:	Biological Products - standards - United States -
標題:	Equipment and Supplies - standards - United States -
標題:	Government Regulation - United States -
電子資源:	http://www.crcnetbase.com/isbn/9781841849201
附註:	Print version record
摘要註:	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
ISBN:	9781841849201electronic bk.
ISBN:	1841849200electronic bk.

FDA regulatory affairs
FDA regulatory affairs / edited by David Mantus, Douglas J. Pisano - 3rd ed.. - Boca Raton, FL : CRC Press, 2014.. - 1 online resource (xii, 387 p.).
Print version record.
Includes bibliographical references and index.
ISBN 9781841849201ISBN 1841849200
Drug developmentPharmaceutical industryDrug ApprovalUnited States Government AgenciesBiological ProductsEquipment and SuppliesGovernment Regulation -- standards -- standards -- United States -- United States -- United States -- United States -- United States -- United States -- United States

Mantus, David

FDA regulatory affairs
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