How Do People at FDA Read Documents On-Screen?

With the substantial move to submitting electronic documents versus paper documents to FDA, it is useful to pause and consider how a regulatory reviewer actually reads a large complex technical document on screen.

Cuppan, Gregory P. Brainery.net (2009). Articles>Scientific Communication>Regulatory Writing>Biomedical

What Reviewers Need to Know About the Regulatory Reader, Continued

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.

Cuppan, Gregory P. Brainery.net (2009). Articles>Scientific Communication>Regulatory Writing