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FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

Description: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

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	Science/Engineering Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices John J. Tobin, Gary Walsh, "Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices"Wiley-VCH \| 2008-09-09 \| ISBN: 3527318771 \| 297 pages \| PDF \| 4,5 MBWritten in a clear and concise style by experienced authors, t ...
	Science/Engineering FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition: Douglas J. Pisano, David S. Mantus Informa HealthCare \| ISBN: 1420073540 \| August 11, 2008 \| PDF (OCR) \| 464 pages \| 7911 KB Examines h ...
	Science/Engineering Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices (ReUp) John J. Tobin, Gary Walsh, "Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices" Wiley-VCH 2008 \| ISBN-10: 3527318771 \| 297 Pages \| PDF \| 7,3 MB Product Description"This book is an excellent reference for peop ...
	Science/Engineering Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and BiologicsPublisher: Birkhäuser Basel \| ISBN: 3764383615 \| edition 2008 \| PDF \| 237 pages \| 1,9 mb At last! The book for anyone who writes regulatory documents or w ...
	FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug appr ...
	Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics Compliance Handbook for Pharmaceuticals, Medical Devicesand Biologicsedited by Carmen Medina ISBN: 0824740785 English -year 2004-704pages-pdf-Size:7,78 MbWhether preparing for regulatory submissions or preapproval, investigator-directed, ...

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	Science/Engineering Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices John J. Tobin, Gary Walsh, "Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices"Wiley-VCH \| 2008-09-09 \| ISBN: 3527318771 \| 297 pages \| PDF \| 4,5 MBWritten in a clear and concise style by experienced authors, t ...
	Science/Engineering FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition: Douglas J. Pisano, David S. Mantus Informa HealthCare \| ISBN: 1420073540 \| August 11, 2008 \| PDF (OCR) \| 464 pages \| 7911 KB Examines h ...
	Science/Engineering Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices (ReUp) John J. Tobin, Gary Walsh, "Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices" Wiley-VCH 2008 \| ISBN-10: 3527318771 \| 297 Pages \| PDF \| 7,3 MB Product Description"This book is an excellent reference for peop ...
	Science/Engineering Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and BiologicsPublisher: Birkhäuser Basel \| ISBN: 3764383615 \| edition 2008 \| PDF \| 237 pages \| 1,9 mb At last! The book for anyone who writes regulatory documents or w ...
	FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug appr ...
	Compliance Handbook for Pharmaceuticals, Medical Devices and Biologics Compliance Handbook for Pharmaceuticals, Medical Devicesand Biologicsedited by Carmen Medina ISBN: 0824740785 English -year 2004-704pages-pdf-Size:7,78 MbWhether preparing for regulatory submissions or preapproval, investigator-directed, ...

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