Federal Drug Administration (FDA) is a federal agency that controls drug and biologics approval process. FDA decisions make or sometime breaks the companies.
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. I personally learned that 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 drug-sponsors adhere to this FDA regulation.
posted by David Usharauli