Books: IND Submissions: A Primer
Posted 01 December 2009 | By
IND Submissions: A Primer is reminiscent of the Betty Crocker cookbook with tabs for easy reference. You can go right to what you need to "cook up" a particular submission, and the book stays open while you read and work. This book contains everything needed for submission of an Investigational New Drug application, including examples of forms already filled out, content templates to start the submission, cover letters and even a CD-ROM with electronic examples. Best of all, the author has a sense of humor and has a way of making dry material easy to read and remember. For example, a section on FDA Form 1571 is titled, "Original, Original, Who has the Original?" (Chapter 5, p. 32). And, each chapter contains concise definitions, glossaries and practical tips that usually are only learned on the job. Overall, the book is designed with readers in mind.