Food and drug law deals with governmental attempts to protect public health and individual welfare in the development and marketing of essential commodities. The materials included in this Third Edition, the organization used, and the issues dealt with reflect this focus. The organization and bibliographic assistance should help frame the pertinent questions and identify many of the relevant sources. The FDA's continuing efforts to come to grips with its regulatory responsibilities comprise a mini-history of American administrative law. Since the 1960's, regulation of food, drugs, and related products has presented some of the most challenging illustrations of the tense interplay between law and science. Because of the growing complexity of its responsibilities and the potential clash between public objectives, the FDA has been forced to experiment with a wide variety of innovative administrative procedures for deciding controversial law-science issues. The story of federal efforts to regulate the marketing of foods and drugs is fascinating as history in itself.
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Most Helpful Customer Reviews
5.0 out of 5 stars
I don't know how much better a textbook should be,
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This review is from: Food and Drug Law (University Casebook Series: Cases and Materials) (Hardcover)
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.
4.0 out of 5 stars
It's a Law Book!,
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This review is from: Food and Drug Law (University Casebook Series: Cases and Materials) (Hardcover)
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.
1 of 2 people found the following review helpful:
2.0 out of 5 stars
Too much info,
This review is from: Food and Drug Law (University Casebook Series: Cases and Materials) (Hardcover)
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.
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