FDA Regulatory Affairs

Name: FDA Regulatory Affairs : Third Edition
Price: 2992.0 NOK
Availability: InStock

Third Edition

David Mantus (Redaktør) Douglas J. Pisano (Redaktør)

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«
"This book covers the myriad of topics related to the development and marketing of all types of drugs and devices regulated by the U.S. Food and Drug Administration. The book discusses not only the relevant regulations, but also the administrative processes that sponsors must deal with in getting their products approved for marketing. ... This book covers many of the important issues in enough depth to answer basic questions related to the components of an IND (investigational new drug) and an NDA (new drug application), as well as IDE (investigational device exemption) and 510k applications. ... This book fulfills a unique need for those seeking a book for a course in drug and device development or for those in the industry who seek information outside of their area of expertise."
—Michael R. Jacobs, BS, PharmD, Temple University School of Pharmacy, in Doody's Book Reviews
»

Examines harmonization of US Federal Food, and Cosmetic Act with international regulations as they apply to human drug and device development, research, and marketing. Focusing on drug approval process, cGMPs, GCPs, quality system compliance, and documentation requirements, this title is suitable for those involved in pharmaceutical regulation. Les mer

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Detaljer

Forlag: CRC Press
Innbinding: Innbundet
Språk: Engelsk
Sider: 400
ISBN: 9781841849195
Utgave: 3. utg.
Utgivelsesår: 2014
Format: 23 x 15 cm

Anmeldelser

«
"This book covers the myriad of topics related to the development and marketing of all types of drugs and devices regulated by the U.S. Food and Drug Administration. The book discusses not only the relevant regulations, but also the administrative processes that sponsors must deal with in getting their products approved for marketing. ... This book covers many of the important issues in enough depth to answer basic questions related to the components of an IND (investigational new drug) and an NDA (new drug application), as well as IDE (investigational device exemption) and 510k applications. ... This book fulfills a unique need for those seeking a book for a course in drug and device development or for those in the industry who seek information outside of their area of expertise."
—Michael R. Jacobs, BS, PharmD, Temple University School of Pharmacy, in Doody's Book Reviews
»