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Regulatory and Medical Writing, A Consultant’s Perspective – Part 3 - Format

Besides audience, another important constraint in regulatory writing is format – the arrangement of type on the page, the typeface, the placement of headings, the method of citation, and so on.  In our world there are often defined formats for reports which limit our ability to address specific audiences.  As medical writers we need to appreciate the need for and the purpose of, set formats while applying our skill at directed communication.

Typing on keyboard

Key to this is a respect for the life and circumstances of the reader.  Agency reviewers, for example, are faced with the challenge of balancing effective review time with industry mandated timelines.  Our success in reaching that reader is directly proportional to our ability to streamline their process – making it easy for them to locate, digest, interpret and reach decisions about the material we are presenting.  This is the ‘art’ of scientific and medical writing in my estimation - Reaching the intended audience within the boundaries of set format considerations.  Achieving success in this aspect of the writing will set a tone of understanding, appreciation and credibility with the reader and will most certainly enhance the review process. 

The barriers in format and design are real and somewhat unmovable.  For that reason, we cannot necessarily affect the outcome to the reader but we can make their road to that outcome more efficient and, even, pleasant.  How can we do that –

  • Clear section headings utilizing titles such that the first 1 – 3 words define their content

  • Narratives that are purpose focused and content driven

  • Tables which present pertinent and important details clearly – large enough to read

  • Figures to depict relationships in information

  • Citations and referencing which easily allow verification of the data

Section headings are usually preset in the field of regulatory writing.  We can impact on their effectiveness through the use of typeface size and presentation – larger, or bolder, etc.  We can also impact through the effective use of sub-headings which are not usually mandated in set guidelines.  Subheadings should be used judiciously and creatively.  In most instances it is important to avoid the lengthy title and choose one that is clearly defined in the first few words.  A bonus to the well thought out subheading is its addition in a table of contents – the reader with interest in only specific information can easily locate it through the simple act of scanning a page.

Watch for Part 4 of this series as we dig deeper into the mechanics of narrative writing.


Regxia's team specializes in preparing clinical and marketing applications. Learn more about our ability to support your next regulatory filing here.

Betty Cory

Author: Betty Cory, President

Regxia Inc.


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