FDA Regulatory Affairs
ISBN-13:
9781420073546
ISBN-10:
1420073540
Edition:
2
Author:
Douglas J. Pisano, David S. Mantus
Publication date:
2008
Publisher:
CRC Press
Format:
Hardcover
464 pages
Category:
General & Reference
,
Chemistry
,
Chemistry
,
Pharmacology
,
Pharmacy
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Book details
ISBN-13:
9781420073546
ISBN-10:
1420073540
Edition:
2
Author:
Douglas J. Pisano, David S. Mantus
Publication date:
2008
Publisher:
CRC Press
Format:
Hardcover
464 pages
Category:
General & Reference
,
Chemistry
,
Chemistry
,
Pharmacology
,
Pharmacy
Summary
FDA Regulatory Affairs (ISBN-13: 9781420073546 and ISBN-10: 1420073540), written by authors
Douglas J. Pisano, David S. Mantus, was published by CRC Press in 2008.
With an overall rating of 4.4 stars, it's a notable title among other
General & Reference
(Chemistry, Chemistry, Pharmacology, Pharmacy) books. You can easily purchase or rent FDA Regulatory Affairs (Hardcover) from BooksRun,
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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.
FDA Regulatory Affairs:
- provides a blueprint to the FDA and drug, biologic, and medical device development
- offers current, real-time information in a simple and concise format
- contains a chapter highlighting the new drug application (NDA) process
- discusses FDA inspection processes and enforcement options
- includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA
Three all-new chapters cover:
- clinical trial exemptions
- advisory committees
- provisions for fast track
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