How FDA Really Works: Insights from the Experts

Edited by Wayne L. Pines and Jessica L. Zeller, with 24 chapters from contributing authors

Table of Contents

Details

Softbound | 288 pages

Print ISBN | 978-1-935065-95-1

E-Book ISBN | 978-1-935065-96-8

Overview

For those seeking to navigate a product application, address a regulatory issue, or establish or change a policy, success in navigating the Food and Drug Administration maze can be formidable. In a first-of-its-kind book, authors who are top experts in their fields share their essential insights from their experiences interacting with FDA—or as FDA employees themselves—to help illuminate the complexities of the regulatory process and provide observations for effectively communicating with the agency.

Learn how to get the most out of your relationship with FDA, whether it’s determining the best way to contact the agency, a question about a specific product area, how to appeal an adverse decision, or tips on the unique culture of FDA. This book provides personal experiences, best practices, and “tricks of the trade” from people who interact with the agency every working day.

Purchase

Member

$129

Members

$159

Non-members

Student

$99

Membership or Proof of Class Required

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.

FAQs

Is there a discount rate for professors?2024-09-04T15:16:52-04:00

Review copies for professors who are adopting a book for a course are available for a reduced fee. Please contact [email protected] or 202-371-1420 for more information.

What is the rate for bookstores?2024-07-26T13:00:56-04:00

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

Do you offer a discount for bulk purchases?2024-09-04T15:15:11-04:00

Yes. Orders of more than 5 books of a single title are eligible for discounts. Larger orders are eligible for larger discounts. Add copies to your cart or contact [email protected] (or call 202-371-1420) for more information!

How are e-books delivered (if available)?2024-09-04T15:14:41-04:00

Electronic books (e-books) are available for many titles. E-books are delivered 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 companion print book.

E-book orders are fulfilled as quickly as possible during business hours (usually within one business day) and are not available for immediate download upon checkout.

What features are included in e-books?2024-09-04T15:13:57-04:00

The e-book platform provides a number of benefits, including in-book annotation, an option for offline reading, and cross-platform syncing. Additionally, the 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.

How long does it take to receive a physical copy?2024-09-04T15:18:02-04:00

Physical copies of books purchased through our website are printed and shipped directly to customers. Printing and shipping times may fluctuate, but the process usually takes 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. 

Please contact [email protected] for more information.

2024-10-22T12:29:26-04:00
Go to Top