What Reviewers Need to Know About the Regulatory Reader, Continued
http://brain.brainery.net/mcblog/?p=295

Cuppan, Gregory P.
Brainery.net
2009

Abstract:

One of the big problems in document review is that reviewers often fail to recognize that their principal job as a reviewer is to act as a surrogate for the document end-user, in this case the regulatory reader. In this article, we offer a characterization of the reading style of the regulatory reader which is useful to keep in mind when reviewing any document or group of documents to be submitted to pharmaceutical and medical device regulatory agencies.