Volume 23, Issue 2 - Regulatory Writing Basics
A guide to pre-approval regulatory documents
Author: Raquel Billiones
Abstract
The following table provides a list of the most common pre-approval regulatory documents for drugs with their associated guidelines and regulations. The clinical study report (p86), clinical study protocol (p93), investigator's brochure (p96), and common technical document (and components; p101) are dealt with in detail elsewhere in this issue.
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