A Practical Guide to FDA’s Food and Drug Law and Regulation, Seventh Edition

Table of Contents

 

Edited by Wayne L. Pines and Stephen M. Kanovsky, with 19 chapters by contributing authors
Softbound | 650 pages
Print ISBN | 978-1-935065-87-6
E-Book ISBN| 978-1-935065-88-3

FDLI’s popular reference book, A Practical Guide to FDA’s Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products.

Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court).

This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

Bookstores should email [email protected] for bulk pricing.

Member

$179
  • +$50 for nonmembers
  • + $50 to add E-Book or Print at Checkout

Student

$129
  • transcripts Required
  • +$30 to add E-Book or Print at Checkout

Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

Save 10% on a purchase of 5 or more copies, save 15% on a purchase of 20 or more copies and save 25% on a purchase of 50 or more copies.

For bookstore bulk pricing, please email [email protected].

Review copies for professors who are adopting a book for a course are available for a reduced fee. Please contact [email protected] for more information.

Physical copies of books purchased through our website are printed and shipped directly to customers. Printing and shipping times may fluctuate, but usually take 3-10 business days to print in addition to standard wait times for UPS Ground shipping (2-4 days). If you would like to expedite the shipping of your book, we can do so for an additional fee. Please contact us at [email protected] or 202-371-1420 prior to your order.  

This electronic book (e-book) is available to you through the VitalSource Bookshelf application, accessible on most mobile devices and computers (view supported devices). After receiving your order, an access code is sent to your email along with directions to create an account and redeem it. E-books are intended for individual use. If you would like a copy of the book that you plan to share with others, FDLI recommends purchasing a print book.

E-book orders are fulfilled as quickly as possible during business hours and are not available for immediate download upon checkout.

The e-book platform provides a number of benefits, including in-book annotation, an option for offline reading, and cross-platform syncing. Additionally, the purchased e-book may be accessed through two mobile devices and two desktop computers at one time. If you are interested in learning more about the features, you can find a full list on VitalSource’s website.