An in-depth guide to writing, editing, tracking, and submitting the original IND and applicable IND amendments
The book provides a "hands-on" approach that will teach Regulatory professionals -- novice and veteran alike -- to work with regulations, guidance documents, content templates, style guides, the necessary information needed to write the document and provide writing tips to produce a range of U.S. drug and biologics submissions that comply with the requirements and are clear to read.
The 600-page, spiral-bound, hardcover book is easy to use that outlines step-by-step on how to plan, write, and submit regulatory documents. Each chapter (62 in total) is divided by easy-to-read tabs and includes a CD filled with electronic examples. It is the ideal resource for new professionals entering the field, a useful training guide, and a valuable reference for the experienced professional.
In this comprehensive "how-to" guide, the following details are contained:
-
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 contained in submission
-
Tips and lessons learned from the author''s experience
-
Different perspectives on how a submission can be approached
-
Paper Publishing Tips
-
Applicable FDA Form 1571 information for each submission
-
Where applicable, the sections of the electronic CTD section items will be slotted
-
Real life examples taken from the press and approved NDAs when available
-
Electronic examples and content templates to utilize so that an RA professionals can begin immediately working on the submission
-
Purchase your copy of the IND Submissions book today!
Read a review by Amy N. Grant, MS of ViroPharma Incorporated
Read a review by Norman M Goldfarb of First Clinical Research
Read an article
Listen to a podcast with the author
About the author:
IND Submissions: A Primer was written by Meredith Brown-Tuttle, RAC, 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, 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 at UC Santa Cruz.