FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition / Edition 2

Hardcover (Print)
Rent from BN.com
(Save 67%)
Est. Return Date: 07/05/2015
Buy Used
Buy Used from BN.com
(Save 37%)
Item is in good condition but packaging may have signs of shelf wear/aging or torn packaging.
Condition: Used – Good details
Used and New from Other Sellers
Used and New from Other Sellers
from $89.97
Usually ships in 1-2 business days
(Save 46%)
Other sellers (Hardcover)
  • All (7) from $89.97   
  • New (1) from $155.60   
  • Used (6) from $89.97   
Sort by
Page 1 of 1
Showing All
Note: Marketplace items are not eligible for any BN.com coupons and promotions
Seller since 2008

Feedback rating:



New — never opened or used in original packaging.

Like New — packaging may have been opened. A "Like New" item is suitable to give as a gift.

Very Good — may have minor signs of wear on packaging but item works perfectly and has no damage.

Good — item is in good condition but packaging may have signs of shelf wear/aging or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Acceptable — item is in working order but may show signs of wear such as scratches or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Used — An item that has been opened and may show signs of wear. All specific defects should be noted in the Comments section associated with each item.

Refurbished — A used item that has been renewed or updated and verified to be in proper working condition. Not necessarily completed by the original manufacturer.

Brand New, Perfect Condition, Please allow 4-14 business days for delivery. 100% Money Back Guarantee, Over 1,000,000 customers served.

Ships from: Westminster, MD

Usually ships in 1-2 business days

  • Canadian
  • International
  • Standard, 48 States
  • Standard (AK, HI)
Page 1 of 1
Showing All
Sort by


Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.

FDA Regulatory Affairs:

  • provides a blueprint to the FDA and drug, biologic, and medical device development
  • offers current, real-time information in a simple and concise format
  • contains a chapter highlighting the new drug application (NDA) process
  • discusses FDA inspection processes and enforcement options
  • includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA

Three all-new chapters cover:

  • clinical trial exemptions
  • advisory committees
  • provisions for fast track
Read More Show Less

Product Details

  • ISBN-13: 9781420073546
  • Publisher: Taylor & Francis
  • Publication date: 8/7/2008
  • Edition description: REV
  • Edition number: 2
  • Pages: 464
  • Product dimensions: 6.00 (w) x 9.50 (h) x 1.00 (d)

Meet the Author

DOUGLAS J. PISANO is Dean of the School of Pharmacy and Professor of Pharmacy Administration, Massachusetts College of Pharmacy and Health Sciences, Boston, Massachusetts, USA. Dr. Pisano received his Ph.D. in Law, Policy, and Society at Northeastern University, Boston, Massachusetts, USA. He is an active member of several professional organizations, including the American Association of Colleges of Pharmacy and the American Pharmaceutical Association. A national speaker and invited lecturer, Dr. Pisano was the recipient of the Special Service Award for the Enhancement of Regulatory Education from the Regulatory Affairs Professionals Society in 2000. He has developed several courses and programs at the Massachusetts College of Pharmacy and Health Sciences in such areas as health policy, pharmacy and drug law, and regulatory affairs. Dr. Pisano, along with coeditor Dr. David S. Mantus, is also the editor of the first edition of Informa Healthcare’s FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics.

DAVID S. MANTUS is Vice President of Regulatory Affairs and Program Management, Cubist Pharmaceuticals, Inc., Lexington; Adjunct Professor of Drug Regulatory Affairs, Massachusetts College of Pharmacy and Health Sciences, Boston; and President, C After D Inc., Boston, Massachusetts, USA. Dr. Mantus received his Ph.D. in Chemistry from Cornell University, Ithaca, New York, USA. He is an active member of the Regulatory Affairs Professional Society and the American Chemical Society and is a frequent presenter and lecturer at national conferences on biologics and biotechnology, regulatory affairs, and vaccine development. Dr. Mantus has also served as chairperson for several conferences, including "Outsourcing Regulatory Affairs" and "Vaccine Development for the 21st Century."

Read More Show Less

Table of Contents

Ch.1 - Overview Of Drug Development And The FDA: Josephine Babiarz

Ch.2 - IND: Michael R. Hamrell

Ch.3 - Formatting, Assembling, And Submitting A CTD (NDA): Charles Monahan III

Ch.4 - Meeting with the FDA: Alberto Grignolo

Ch.5 – Biologics: J. Kenimer

Ch.6 - FDA Medical Device Regulation: Barry Sall

Ch.7 - The Development of Orphan Drugs: Tan Nguyen

Ch.8 - Chemistry, Manufacturing and Control Issues: Drugs and Biologics: Prabu Nambiar

Ch. 9 - Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices: Robert Buckley

Ch.10 - The Regulation of Promotional Materials And Advertising For Drugs: Karen Drake

Ch.11 - CTD SUBMISSIONS: A Guide For Electronic Regulatory Submissions to FDA: Shylendra Kumar, Yolanda Hall, Vahé Ghahraman

Ch.12 - The Practice Of Regulatory Affairs: Dave Mantus

Ch. 13 - A Primer Of Drug/Device Law Or What's The Law And How Do I Find It? Josephine Babiarz

Ch.14 - Advisory Committee System at FDA: Christina McCarthy

Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star


4 Star


3 Star


2 Star


1 Star


Your Rating:

Your Name: Create a Pen Name or

Barnes & Noble.com Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & Noble.com that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & Noble.com does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at BN.com or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation


  • - By submitting a review, you grant to Barnes & Noble.com and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Noble.com Terms of Use.
  • - Barnes & Noble.com reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & Noble.com also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on BN.com. It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)