Customer Reviews

Food and Drug Law (University Casebook Series: Cases and Materials)

5 star:		(1)
4 star:		(1)
3 star:		(0)
2 star:		(1)
1 star:		(0)

 

 

I really like this textbook because it gives a context of how the current law came about. There are synopsis of cases instead of gazillion pages of useless information, as in some other casebooks. This is a great FDA law reference. The rest of the things you need to know are on the FDA website. Lastly, it's $65 cheaper than the COOP price.

Those in Law:
As good as other casebooks. Lengthy (details) and never highlight "important" stuff . What is not important?
Skipping the fine prints is never a good idea. 1700 pages is pretty routine.
4-star because I can't say it's the best. It is the best FDCA case book I have so far (not planning to read another).

Those in pharma/chemical/biopharma....:
To use this 4.5 kg book to understand cGMP, NDA etc is probably impractical, if you need those info for "practical" reasons.
Why would you want to know FDA started from a small office? Or, what the "Congress" wanted or intended, like 20 years ago?
If your questions are "how do I get this done", "what should I/shouldn't I do" there are those 300-pages A5 sized book that encapsulate all topics. Those books would high light the landmark cases and explain concisely what thou must/must not.
The FDA website provides plenty of up to date info.

However, reading this Food and Drug Law would give you a whole picture of FDA and FDCA; and the frequency of you saying "what? That's ridiculous" would be reduced. Sometimes people tell that they've found a loop hole, not knowing that each word is clearly defined.

If you are taking a class for regulatory purpose and hence using this book, get a 300-page all-you-need-to-know book and note the cases that are mentioned - those are usually the landmark cases. Pay attention to the ramifications and the arguments.
Those in regulatory should get one. It will reduce the chances of a company getting a warning letter.

Like Chris C, i found the book waaay too wrapped up in the history. And hard to read. The writing on the page just doesn't convey knowledge well. You will read through a LOT of info, and then read over the 2 most critical/important points without realizing their significance at all, because they are not highlighted by the authors. You will get 50-page assignments for class (yes, the text is smaller and the pages are bigger than a normal textbook), which was freakin 50 pages because the book is sooo tedious and throws out the critical bits of information here and there scattered.

This is not just a textbook. It is a tome of Hutt's knowledge. Knowledge you'll wish your glazed eyes never had to be dragged over.