Lean Authoring and the Strategic Role of the Regulatory Writer

Regulatory writing is often seen as a form of writing that is rigid and does not involve creativity. Although partly true, regulatory writing is not at all mundane because it requires industry knowledge and strategic thinking so the document can effectively serve its purpose prior to and beyond regulatory approval. Regulatory documents must deliver specific and accurate messages to their end readers—regulatory authorities—who do not read front-to-back as most of us do. 

Regulatory authorities often have tight deadlines to review submissions; therefore, regulatory writers must know what and how information needs to be written down in each section such that reviewers can easily find the information they need to answer questions they may have concerning safety, efficacy, or adverse events and their severity. Regulatory writing is a skill that requires practice and experience; it’s a lot more than following templates or copying and pasting.

Lean authoring is a style of regulatory writing that has gained attention in recent years. It means finding a balance between writing less and still presenting the complexity of clinical trial data in full clarity. For example, Gregory Cuppan, in his article titled “Why the Concept of ‘Thinking, Fast and Slow’ and Lean Writing Matter in Authoring Regulatory Briefing Books,” discusses the importance of presenting visually appealing regulatory documents to regulatory reviewers (1). Having short sentences, short paragraphs, tables, and figures helps reviewers’ eyes parse information quickly. 

Further, in his book titled Writing for the Biopharmaceutical Regulatory Reader, Cuppan explains the “modified F” reading pattern, in which reviewers are likely to move their eyes along the left side of a page when searching for keywords, and only when they spot relevant ones do they read the whole paragraph (2). Accordingly, putting topic sentences at the beginning of each paragraph is advisable—a practice known as deductive writing. 

Another way to improve clarity is by using hyperlinks to connect different parts of a dossier, thereby avoiding the need to repeat information. Also, just as in other forms of writing, using clear and concise language helps reduce the cognitive load of regulatory reviewers, which results in faster review of regulatory documents.

Why Lean Authoring?

Lean authoring is desired simply because regulatory authorities prefer clear and concise writing. 

Based on the Center for Drug Evaluation and Research (CDER) Manual of Policies and Procedures (MAPP) 6030.9 titled Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review, CDER review staff expect sponsors to provide well-organized and complete submissions in accordance with the high-level content and formatting recommendations described in the MAPP. Incomplete or confusing submissions will be deprioritized in the review process. Lean authoring is one way to prevent confusion by providing clear and concise writing. 

Lean authoring benefits not only regulatory review processes but also internal review processes. It helps regulatory writers cut down the number of pages of regulatory documents, improving readability and productivity. Having a lean document will also help in future AI tool adoption because verbose text makes it difficult for AI to identify and isolate information (3).

Despite these benefits, lean authoring adoption often faces challenges because sponsors and stakeholders may not be familiar with it.3 Document contributors often have a tendency to add more information than is needed, with the thought that regulatory reviewers might want to see it. This misconception is counterproductive, as it can delay the regulatory review process. 

Regulatory writers are the ones who can educate and guide document contributors on their writing styles, including lean authoring. Further, regulatory writers may champion change management, leading to leaner documents for the benefit of all. 

Key Takeaways

• The role of regulatory writers goes beyond simply writing regulatory documents. 

• Writers need to understand the regulatory authority’s perspective when writing regulatory documents and use lean authoring techniques to reduce reviewers’ cognitive load. 

• Lean authoring is key to a fast and efficient regulatory review process. 

• Regulatory writers hold an important role in educating, guiding, and championing changes toward a leaner writing style.

References

1. Cuppan GP. Why the concept of “thinking, fast and slow" and lean writing matter in authoring regulatory briefing books. LinkedIn. July 2, 2024. Accessed October 12, 2026. https://www.linkedin.com/pulse/why-concept-thinking-fast-slow-lean-writing-matter-authoring-cuppan-8mlzc

2. Cuppan GP, Bernhardt SA. Writing for the Biopharmaceutical Regulatory Reader. 2nd ed. McCulley/Cuppan Inc; 2025. 

3. Geary L, Nielsen IØ, Charron F, et al. Optimizing clinical study report development through lean authoring: a framework for meeting regulatory expectations and preparing for automation. Ther Innov Regul Sci. 2026;60(5):1232-1246. doi:10.1007/s43441-026-00980-6 

About the author: Grace Pohan is a freelance medical writer with an interest in regulatory writing. She earned her MASc in chemical engineering from the University of Waterloo and her BEng in bioengineering from the National University of Singapore. She obtained a certification in regulatory writing from the University of Chicago and a certification in regulatory documents from AMWA Education. Grace brings a decade of scientific research experience spanning enzymatic and high-throughput assay development, neurodegenerative diseases, and vascular tissue engineering.