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Barnett Releases IND Submissions: A Primer
Date:2/25/2009

Barnett International, a division of Cambridge Healthtech Institute, has announced the release of IND Submissions: A Primer, an in-depth guide to writing, editing, tracking, and submitting the original IND and applicable IND amendments. IND Submissions: A Primer is the only comprehensive IND manual of its kind.

Needham, MA (PRWEB) February 25, 2009 -- 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.

The 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.

IND Submissions: A Primer is the ideal resource for new professionals entering the field, a useful training guide, and a valuable reference for the experienced professional. This comprehensive "how-to" guide contains:

  • 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
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