Clarity in Motion: How Writing Actions Drive Plain Language in Regulatory Documents

​You’ve heard it before: plain language is essential to effective regulatory communication. I have
discussed this topic many times—writing that avoids jargon, long sentences, and convoluted phrasing
improves readability. But here is the problem: plain language does not always help the reader
understand what matters—or what to do with the information.

A sentence may be grammatically simple, technically correct, and jargon-free—and still be useless to a
regulatory reviewer or clinical research manager trying to make a decision. Clarity is not just about
words. It is about what those words are doing. That is, the action of meaning.

Action of meaning refers to how writing should do more than just state facts. The action within writing is
shaping how facts are understood. The approach involves selecting, organizing, and connecting
information so that the reader grasps why it matters. In regulatory writing, the action is to turn data into
insight and support decision-making.

Plain language is necessary—but not sufficient. To achieve true clarity in regulatory
documents—especially those designed to inform regulatory judgment—we need more. We need writing
actions: carefully orchestrated rhetorical moves that position, prioritize, and connect information with
intent.

What Are Writing Actions? Writing actions are deliberate moves that shape how information is
delivered. Each action—such as previewing, overviewing, summarizing, and synthesizing—serves a
distinct purpose, helping the reader understand what’s being said, why it matters, and how to act on it.
These actions give structure and direction to plain language text. The actions guide attention and
support decisions.

What Plain Language Does Well
When done well, plain language:

• Reduces sentence complexity
  
• Removes unnecessary jargon
  
• Improves accessibility for time-constrained and multilingual readers
  
• Helps avoid ambiguity and interpretive drift

Plain language makes content easier to decode. But decoding is not the same as understanding.

Where Plain Language Falls Short
Even a well-written sentence can feel out of place if it does not:

• Serve a clear function in the paragraph or section
  
• Connect to what came before or what’s coming next
  
• Support the document’s argument, evaluation, or justification

Plain language improves readability. Writing actions improve clarity to enable usability.

In the book I co-wrote with Stephen Bernhardt --Writing for the Biopharmaceutical
Regulatory Reader (2nd Edition)—we dedicate over 60 pages to discussing 11 writing
actions. We consider these actions to be the rhetorical moves that turn information into
insight.
Four Writing Actions That Boost Clarity
1. Preview
Previewing sets expectations. The writing action is a “framing” technique. The action
positions the reader to absorb the information with the proper context and connect it to
the larger purpose of the document.
Example:
This section evaluates the safety profile of the investigational monoclonal antibody
using pooled data from five 26-week studies conducted in North America, Europe, and
East Asia. The focus is on treatment-emergent adverse events, serious infections, and
discontinuations. Data from subgroups—by age, comorbidity, and prior biologic
use—are also included to support regulatory interpretation of risk across diverse patient
populations.
Why it works:

• Starts with action: evaluates the safety profile
  
• Establishes context: pooled, multi-regional, 26-week studies
  
• Signals structure: TEAEs, infections, discontinuations
  
• Aligns with regulatory expectations (subgroup analyses)
  
• Lean and purposeful (3 sentences, ~60 words)

Another strong preview example comes from an ODAC briefing document prepared by a FDA medical
review team.
Example:
This document discusses the relevant data from individual studies leading to the approvals of nivolumab
and pembrolizumab for the first-line treatment of unresectable or metastatic HER2-negative gastric
adenocarcinoma as well as the data submitted to support approval of tislelizumab for the same
indication. The aggregated experience with these independent trials and products provides a framework
to discuss the strength of evidence for PD-L1 expression as a predictive biomarker for patient selection in
this patient population, differing risk-benefit assessments in different subpopulations defined by PD-L1
expression, and adequacy of the cumulative data to restrict the approvals of immune checkpoint
inhibitors based on PD-L1 expression.
Why it works:

• Establishes purpose and scope without repeating background
  
• Outlines the analytical framework: predictive biomarker value, subgroup risk-benefit, and adequacy of evidence
  
• Uses neutral, forward-looking language—this is setup, not conclusion

2. Overview
Overviews are selective, not comprehensive. Overviews highlight the most important ideas in a
document, section, or dataset. The writing action is to orient the reader to the "So what did we learn?"
message or key findings. Overviews often use interpretive language that signals importance but defers
delivery of precise numerical support to later sections of the document.
Example:
The clinical trials have demonstrated DTG’s antiretroviral activity and safety in various settings. Key
safety observations include:

• No clinically significant trends in post-baseline-emergent hematology abnormalities
  
• Limited safety implications from theoretical or actual drug–drug interactions
  
• Renal safety profile comparable to RAL and EFV in Phase III studies
  
• Hypersensitivity is an uncommon but recognized risk
  
• Drug-related hepatitis is uncommon across all populations and doses
  
• No increased risk of torsade's de pointes

Why it works:

• Signals safety dimensions: hematology, DDIs, renal, immune, hepatic, cardiac
  
• Prepares the reader for deeper analysis in coming sections
  
• Frames the discussion without over-interpreting
  
• Uses bullets for fast retrieval and pattern recognition

Overviews differ from summaries. Overviews come first—they orient the reader to the scope and
structure of the content that follows. Summaries come later—they distill key details after the content
has been presented.

3. Summary and Synthesis: Writing Actions That Inform
If preview and overview frame, then summary and synthesis inform. These writing actions appear after
data presentation to help the reader interpret and apply what they have just consumed.

Summary distills the most important details. A summary does not repeat the data—it distills and
prioritizes. Summaries help readers confirm “So what?” messages, locate key conclusions, and prepare
for comparison across family or families of data.
Synthesis goes further. This writing action is all about connection. The writing action links evidence
across trials, endpoints, or populations—identifying relationships, patterns, and meaning. Synthesis is
essential when articulating benefit-risk tradeoffs, justifying dose, or drawing conclusions across complex
data sets.
Together, these actions help readers move from detail to decision. Summarizing and synthesizing are
not reporting—the actions are to distill and contextualize.

Final Word: Activate Plain Language with Purpose
Plain language improves reader access, but writing actions give meaning and direction to language.
Preview and overview frame expectations and focus attention. Summary and synthesis inform the
reader—distilling evidence, revealing connections, and guiding decisions. Together, these writing actions coupled with plain language writing make regulatory documents clearer, faster to navigate, and more
useful to those who must act on them. Clarity in regulatory writing is not only about managing
paragraphs, sentences, and words. It is about activating them with purpose. That is, enabling the action
of meaning.