FDA Regulatory Affairs

by David Mantus (editor), Douglas J. Pisano (Editor)

This third edition of FDA Regulatory Affairs 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. Focusing on new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements this is a key title for anyone involved in pharmaceutical regulation. Jargon-free and drawing information from a wide range of resources, this book demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

Genres: Nonfiction

400 pages, Hardcover

First published December 23, 2003

Reviews

[Geetanjali · Rating 4 out of 5]

Amazing book

[David Usharauli · Rating 3 out of 5]

This book, edited by Douglas Pisano and David Mantus, is a compilation of FDA related regulations and law applicable to biotech/biopharma drug development.

Of course, no single book can provide full picture of FDA. Though I would say this book does some decent job, especially one chapter with tips how to find FDA related information online. Chapter about IND is also quite good.

Primary interest in this book from scientist's point of view are chapters about IND and NDA applications. For example, new law enacted in 2012 increased by 60 days both standard and priority review times necessary for NDA processing (8 months for priority review and 12 months for standard review).

Also, I learned that until FDA approves new drug, drug manufacturer or its associates cannot mention anywhere that their drug is "safe" or "effective". I did not realize that such rule existed. In my work, I frequently encounter science articles where IND/NDA-associated drug is discussed. I have not paid attention before but now it will interested to verify how strongly drug-sponsors adhere to this FDA regulation.

posted by David Usharauli

http://davidusharaulibookidealist.blo...

[Aca · Rating 5 out of 5]

Generous, straightforward and not overwhelming introduction to FDA regulations and components.