Guidebook for Drug Regulatory Submissions / Edition 1

Hardcover (Print)
Used and New from Other Sellers
Used and New from Other Sellers
from $88.20
Usually ships in 1-2 business days
(Save 26%)
Other sellers (Hardcover)
  • All (8) from $88.20   
  • New (7) from $94.88   
  • Used (1) from $88.20   

Overview

Destined to become every regulatory director's essential desktop companion

rofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.

Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines.

As well, vital information is provided on the most common types of submissions, including:

  • Meeting Requests
  • Orphan Drug Applications
  • Investigatory New Drug Applications (INDAs)
  • New Drug Applications (NDAs)
  • 505(b)2 NDAs
  • Abbreviated New Drug Applications (ANDAs)
  • Annual Report

This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia.

Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.

Read More Show Less

Editorial Reviews

From the Publisher
“The Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development.” (Pharmaceutical Outsourcing, April 2009)
Read More Show Less

Product Details

  • ISBN-13: 9780470371381
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 3/11/2009
  • Edition description: New Edition
  • Edition number: 1
  • Pages: 379
  • Product dimensions: 6.30 (w) x 9.30 (h) x 2.80 (d)

Meet the Author

SANDY WEINBERG is the former Vice President for Regulatory Affairs and Quality Assurance at Tikvah Therapeutics, Inc., and is now Associate Professor of Health Care Management and Director of the Master in Health Administration Graduate Program at Clayton State University in Atlanta. He has thirty years of experience in the field of drug regulatory affairs and is the author of twelve books, most recently Good Laboratory Practice Regulations, Fourth Edition.

Read More Show Less

Table of Contents

Preface ix

Chapter 1 Ten Rules for Drug Regulatory Submissions 1

Chapter 2 FDA Meeting Requests 44

Chapter 3 Orphan-Drug Applications 64

Chapter 4 Investigational New Drug Applications (INDs) 82

Chapter 5 New Drug Applications (NDAs) 120

Chapter 6 505(b)2 New Drug Applications (NDAs) 183

Chapter 7 Abbreviated New Drug Applications (ANDAs) 255

Chapter 8 Annual Reports 288

Chapter 9 International Regulatory Submissions Carl A. Rockburne 315

Chapter 10 Future Issues in Regulatory Submissions 355

Index 367

Read More Show Less

Customer Reviews

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

5 Star

(0)

4 Star

(0)

3 Star

(0)

2 Star

(0)

1 Star

(0)

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

Reminder:

  • - 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)