Ind Submissions: A Primer

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.