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IND Submissions: A Primer, by Meredith Brown-Tuttle, RAC
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IND Submissions: A Primer provides a hands-on approach that teaches regulatory professionals novice and veteran alike to work with the regulations, guidance documents, content templates, contributing authors, and style guides necessary to write an IND. The book s writing tips show regulatory professionals how to produce a range of U.S. drug and biologics submissions that comply with the requirements and are also clear to read. Included with the book is a CD filled with electronic examples. IND Submissions: A Primer is the only comprehensive IND manual of its kind. This 600-page, spiral-bound, hardcover book is easy to use, providing step-by-step instructions on how to plan, write, and submit regulatory documents. Each chapter (62 in total) is divided by easy-to-read tabs. It is the ideal resource for new professionals entering the field, a useful training guide, and a valuable reference for the experienced professional. Specific topics include: * Regulations and guidance document references. * Overview and background of why the submission is required. * Structure of the submission itself. * Details on who should contribute to the submission. * Where to pull, re-use, or start as a basis for information needed in a submission.
* Tips and lessons learned from the author's experience. * Different perspectives on how a submission can be approached. * Applicable FDA Form 1571 information for each submission. * Paper publishing tips.
* Electronic CTD publishing sections for each submission, where applicable. * Real life examples taken from the press and approved NDAs when available. * Electronic examples and content templates to utilize so that an RA professional can begin immediately working on a submission.
- Sales Rank: #239065 in Books
- Brand: Brand: Parexel Intl Corp
- Published on: 2009-02-27
- Original language: English
- Dimensions: .0" h x .0" w x .0" l,
- Binding: Ring-bound
- 530 pages
- Used Book in Good Condition
About the Author
Meredith Brown-Tuttle, RAC, is a regulatory consultant whose background incorporates all aspects of drug, device, and biologics development including clinical research, data management, medical writing, and regulatory affairs. She served for six years on the Board of Editors for the Regulatory Affairs Professional Society s journal, Focus, and has published numerous articles, edited books and book chapters, and presented at professional meetings on a variety of clinical research and regulatory topics. Ms. Brown-Tuttle also teaches about regulatory submissions, intelligence, strategy, and agency interactions for the Regulatory Affairs Certificate program at UC Santa Cruz.
Most helpful customer reviews
5 of 5 people found the following review helpful.
A good reference book for regulatory professionals
By S. Pandya
I came across "IND Submission: A Primer" as a text book for a class taught by the author, Meredith Brown-Tuttle. Since taking the class the red book has become my favorite reference book.
A Primer is a step by step guide that covers a wide range of topics for IND submissions, starting from style guides, submission planning to publishing. IND submission process starts with a pre IND meeting with the FDA. The writing and compilation of various sections of the IND follows. There is also a section on writing amendments to an IND. Each step includes a list of guidance documents and regulations. The book also walks you through the steps involved in IND review at the FDA in anticipation of questions and queries from the FDA.
The red spiral bound book comes with a CD filled with templates for preparing a submission in CTD as well as traditional formats.
By using the IND as the main focus of the book, the author has managed to cover topics that can be useful as reference for writing a host of regulatory documents.
3 of 3 people found the following review helpful.
A must have book
By J. Zhang
This book is right for persons at all levels. If you just want to know what regulatory affairs about, you will get the idea easily by scanning through the book; if you want to file a IND, that is fine, this book guides you step by step to do this job. In addition, this books comes will a CD which covers almost every aspect of IND filings for your reference. On the other hand, if you are a veterans in this field, this book is still useful to you, as it not only be a fantastic reference book at your desk, it also include various technical helps for IND filing, including how not to do in a lot of cases. Hi, you do not mind to have a veteran to watch your back, right?
The author clearly know what she is doing, and have spent a lot of time on it. The word is that IN FACT, some FDAers actually use this book for their references. For a new people like me in this field, I truly enjoy all those communications included in the CD section, and love it.
0 of 0 people found the following review helpful.
Excellent reference book for IND submissions
By Dmitry Kryndushkin
I am a regulatory professional and I am using this book for my work in a biotech company. It provides a comprehensive overview of the submission process. It also contains working examples on the separate CD disk.
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