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The real performance of a regulatory briefing book is not measured by page count or polish. It is measured by how efficiently a regulatory reader can follow the logic, test it, and reach a defensible position on the sponsor’s ask.
Unfortunately, many briefing books still make the reviewer work too hard. They are organized by how teams built the data—not by how regulators make decisions. That misalignment sounds minor, but it has profound cognitive consequences. The Hidden Cost of Misalignment When a document mirrors internal development logic instead of regulatory reasoning, the reader must reverse-engineer the argument. The regulatory reader sifts through design history (“the largest study ever planned in this patient population”) to locate decision relevance. They assemble fragments of details and data to reconstruct the sponsor’s logic trail. Each mental step adds friction—time, effort, and uncertainty. The concept of friction is not to be underestimated. Legal scholar Brett Frischmann describes friction as resistance or drag built into documents used in legal and regulatory decision processes. Cass Sunstein and Richard Thaler refer to unnecessary complexity in documents as sludge—“bad friction” that drains cognitive energy and delays decisions. In regulated markets, economists have quantified these effects. Studies in The Quarterly Journal of Economics and the American Economic Review show that even modest “choice frictions” in Medicare decisions significantly slow and distort judgments. The parallel for regulatory writing is direct: when reasoning is hard to trace, decision friction rises. I often tell clients that their briefing book delivers information but fails to deliver understanding. Common Patterns of Friction
Tables without interpretive anchors that leave reviewers to construct meaning. Massive appendices meant to prove thoroughness rather than aid reasoning. Each of these choices forces reviewers into reconstruction mode. They also trigger what cognitive-load theorists call the split-attention effect—when information that must be mentally integrated is physically separated across pages, tables, or sections. John Sweller’s research in applied cognitive psychology shows that split attention increases working-memory load, slows comprehension, and makes readers less confident in their conclusions. In briefing books, the effect appears when a data table sits ten pages from its interpretation or when related safety and efficacy evidence live in separate silos. The reader’s mind does the integration work the document should have done. And when reviewers must reconstruct logic, decision friction increases and confidence declines. Reviewers start to question not only the data, but the sponsor’s grasp of its own argument. A document that cannot show its reasoning clearly invites more information requests, longer review cycles, and less trust in sponsor judgment. The Decision Pathway Decision-enabling design exists to solve this exact problem. My vision of information design reorganizes briefing content around the decision pathway—the same mental sequence reviewers follow when testing an argument: Issue → Evidence → Interpretation → Position → Request This sequence is not arbitrary. It mirrors both the FDA Benefit–Risk Framework (issues → evidence → appraisal → conclusion) and the structure used in legal briefs (Issue → Rule → Application → Conclusion). Across disciplines, this logic flow has proven to reduce cognitive friction and increase confidence in reasoning. When that sequence is built into the structure, reviewers stop searching for logic and start evaluating reasoning. That shift—from retrieval to evaluation—is the defining mark of a well-designed briefing book. The Shift: From Information Display to Decision Design Teams often assume that completeness equals clarity. It doesn’t. Regulatory readers don’t reward density—they reward traceable reasoning. A decision-enabling design builds its logic trail around the reviewer’s task. Each section of the book should answer one implicit question: What decision does this content support, and what evidence makes it reasonable? When that sequence is visible, reviewers stay oriented. When it’s hidden, they reconstruct it—usually with lower confidence and more questions. The Hallmarks of Decision-Enabling Design A. Purpose-Anchored Structure Each major section begins with the So what?—why the issue matters and what decision is needed now. This tells reviewers not just what they’re reading, but why it matters. B. Progressive Disclosure Information flows from summary → key evidence → traceable detail. Reviewers can engage at any level of depth without losing sight of the reasoning line. C. Decision Cues at the Point of Use Tables and figures are placed where the decision occurs—not buried in appendices. Each display answers a single regulatory question and closes the loop with interpretation, not adjectives. The Result: Cognitive Efficiency, Not Rhetorical Flourish When design mirrors the decision process, cognitive load drops. Readers no longer have to infer your logic; they can inspect it. Review becomes faster, more confident, and less adversarial. That is the quiet power of decision-enabling design: the approach turns information into defensible reasoning—and does so on the regulatory reader’s terms. The Takeaway A decision-enabling briefing book doesn’t argue harder. It argues smarter. It lets structure do the heavy lifting and keeps reasoning in full view. When regulatory teams master this design discipline, meetings change. Regulatory readers spend less time asking “Where does this fit?” and more time discussing “What does this mean for the development program, the patient and the label?” That’s the point—clarity that enables decision. Join the conversation on LinkedIn: https://www.linkedin.com/pulse/decision-enabling-design-how-briefing-books-should-think-cuppan-3pa7c
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Regulatory documents are judged not only by what they say, but by how efficiently the documents help regulatory readers decide. Let’s keep in mind that every document you produce that ends up appearing on the computer screen of a regulatory agency reader is intended to be an advisory document. A document intended to aid the reader in making decisions.
However, my experience suggests that many development teams do not fully appreciate this point. Teams tell me they are in the business of reporting. Teams measure quality by format compliance, data completeness, or adherence to templates — not by decision efficiency. You are not in the reporting business. You are in the business of advising. This judgment gap on “what documents do” explains why many submissions are technically correct but cognitively exhausting to read. Most regulatory documents fail not because they are incomplete, but because they are opaque to reasoning. Regulatory readers are not struggling to find data — they are struggling to follow the thinking behind the data. Every table, paragraph, and conclusion should serve one purpose: to let the reviewer see how evidence informed our thought processes and contribute to decision-making. Regulatory reviewers do not need more information. They need better reasoning access — clear logic, visible connections, and writing that mirrors how decisions are made. Decision efficiency measures how well a document enables a regulatory reader to:
Keep in mind that regulatory readers are auditing reasoning associated with study design, conduct, and data sets. When insight into sponsor reasoning pathways are nonexistent or blocked, the cost is real. This is where the friction comes into play—the reviewer should not have to backtrack, infer, or guess. Reviewers spend time reconstructing logic that writers should have made transparent. Dense text, redundant tables, and poorly signposted arguments force readers to think about the document rather than through it. Each moment of confusion compounds uncertainty. Confidence in the sponsor’s reasoning drops, and the agency’s questions multiply. This is not inefficiency of time — it is inefficiency of thinking. The inefficiency of thinking is the far more dangerous dimension. It erodes trust, clouds the evidence trail, and converts clarity into doubt. In an environment where regulatory review cycles are compressed and AI tools assist human readers, the ability to think clearly through a document — not merely within it — is the new competitive advantage. Decision efficiency evaluates the clarity and logic density of a document — not the volume of its words. At McCulley Cuppan, we define decision efficiency through three observable dimensions:
Why This Metric Matters Now Regulatory authorities worldwide are integrating AI-assisted review tools that rely on structured reasoning and clear metadata. Decision efficiency determines whether those tools (and human reviewers) can interpret content without manual intervention. In this context, poor writing is not just a style flaw — it is an information-access problem. A document with low decision efficiency hides logic behind noise. Moving from Compliance to Cognition Teams that focus only on compliance write to satisfy checklists. Teams that focus on decision efficiency write to support thinking. This shift transforms how review rubrics, templates, and training are used:
This is the next frontier of quality in regulatory writing. Decision efficiency is emerging as the missing metric — the measure that predicts whether a document will accelerate or delay regulatory decision- making. Future articles in this series will show how to design decision-efficient documents, measure them with structured rubrics, and visualize reasoning clarity through AI-enabled analysis dashboards. Behind every table, figure, and p-value lies one purpose: persuading regulatory readers that your interpretations are built on logical evidence-based analyses. In the workshops I facilitate, participants always hear me invoke: “regulatory writing is not neutral—it is strategic.” Each justification is an argument that the data are reliable, the analyses reproducible, quality is consistent, and the benefit–risk balance acceptable.
Persuasion in this context is not simply rhetoric. It is “confidence engineering”—helping regulatory readers reach well-supported decisions quickly and with trust. Why Persuasion Matters in Regulatory Writing Briefing books and Module 2 submission documents go beyond summarizing data. They exist to justify scientific and development choices—to explain why a development program, design, or conclusion deserves confidence. Regulatory reviewers approach every document with professional skepticism. They must confirm that claims are supported, methods are sound, and limitations are acknowledged. Writers who anticipate these needs—by shaping information to mirror how reviewers think—make decision-making easier. The goal is not to impress regulators with volume (I have clients who still want to “bulk up” documents). Rather, it is to enable clear judgment through structure, logic, and transparency. Start Where the Reader Starts — Lead with the Conclusion Regulatory readers read for certainty. Lead with your conclusion, then show how the evidence earns it. Use a top-down flow:
selective, and purpose-driven. Signal Your Logic, Don’t Bury It Regulators look for explicit markers of reasoning. Framing phrases act as cognitive signposts:
and reinforce transparency—a hallmark of credibility. Comparison Is the Language of Persuasion Regulatory readers judge claims in context, not isolation. Comparative framing strengthens justification by positioning your evidence within a known landscape.
relevance. Readers Follow Logic, Not Chronology A strong justification follows a predictable rhythm: Why → How → What.
interpretive burden. Regulatory writing, done well, aligns with how reviewers think, process, and decide. That is the science of persuasion: clarity as method, structure as reasoning, and trust as outcome. For years, eCTD v3.2.2 has been the backbone of global regulatory submissions. It gave structure,
consistency, and a common language for sponsors and regulators. But today, our products and the data behind them have outgrown the rigid folder hierarchy of this eCTD platform. eCTD 4.0 is not just a technical upgrade. It is a shift toward data-centric, decision-ready submissions designed to match how regulators actually read and decide. Why eCTD 4.0—Built for modern product complexity For eCTD v3.2.2, the backbone of a submission is a fixed folder tree. Each document must be placed in a rigid location with a pre-defined name. A concept that works well for small molecules and many biologic submissions with predictable sections. But this rigidity creates friction when you add new data streams. For example, emerging therapies like CAR-T cell products and CRISPR-based gene editing make this challenge sharper. These products generate new evidence categories. Such as, chain-of-identity and chain-of-custody records for each patient’s cells, highly specialized potency assays, and genomic off- target analysis for edited cells. Under eCTD v3.2.2, sponsors often wedge these data sets into ill-fitting sections or invent new folder labels The result is added complexity for the regulatory reviewer. Instead of following an established mental map, regulators must pause to interpret where the information sits, why it’s there, and potentially how it links to other evidence. That extra interpretive work most likely increases cognitive load—the mental effort needed to find and integrate meaning. As I have discussed in other articles, high cognitive load slows review, raises the risk of misinterpretation, and invites clarifying questions or requests for additional information. eCTD 4.0 reduces these problems with a metadata-first model. Instead of forcing content into a physical place, each document or data set is described by rich metadata. The metadata provides terms for data type, data source, and regulatory intent. These metadata elements become the “coordinates” for regulators to find what they need. On top of metadata sits “Context-of-Use” tagging. This is a way to declare why the document exists and how it is meant to be used in the dossier review. For example, a potency assay file might carry context tags such as:
In information design, as I teach it in my workshops, an advance organizer is a signal placed before complex material to help the reader build a mental map. By explicitly stating why a document or data set exists and how it will be used in decision-making enables Context-of-Use tags to work in the same way. The tags prepare reviewers to integrate what they are about to read, reduce search time, and anchor interpretation. Instead of scrolling between sections or inferring meaning from file names, the reviewer sees at a glance the analytical or regulatory task the content supports. This is a cognitive service. Over the course of a 200,000+ page submission, reducing even small interpretive friction compounds into meaningful efficiency and fewer avoidable queries. The result: a scalable submission structure. You can introduce new modalities and data types without breaking the CTD map. Reviewers can filter and navigate by function and relevance, not just by where you tucked the file. And you can maintain submission integrity over time — updates to metadata or context can clarify meaning without re-life cycling the entire file. Instead of duplicating entire documents across IND, NDA, BLA, and global variations, eCTD 4.0 uses unique document identifiers and machine-readable metadata to let the same content unit be updated and referenced throughout a product’s lifecycle. This reduces redundant authoring, helps maintain consistency across submissions, and supports automation for publishing and review. Lastly, richer metadata, stable document identity is now critical as regulatory agencies pilot AI tools for comparison, safety signal detection, and labeling review. A well-tagged eCTD 4.0 dossier will be easier for both humans and machines to navigate. Global Status
For organizations ready to adapt, eCTD 4.0 isn’t just compliance work. It’s a chance to modernize regulatory writing, improve clarity and traceability, and align better with how reviewers — and soon their AI assistants — read and analyze submissions. Further Reading
So what? The way regulatory and medical writers design document hyperlinks now influences not only how efficiently human reviewers read but also how effectively AI tools, like FDA’s Elsa, parse, cross- reference, and retrieve content. Link design is no longer a simple way to manage information economy as defined within lean writing precepts. Link design directly shapes comprehension for humans and interpretability for machines.
The Human Reader Challenge Many biopharma document users must read under time pressure. They work within and across long documents with dense appendices, moving between summary sections, data, methods, and supporting detail. Poorly structured links force them to jump back and forth with little context. That jump is not harmless. Cognitive psychology highlights two distinct challenges:
The result: reviewers not only lose the argument thread but also misinterpret the evidence when links overshoot or underserve their purpose. Poor link design magnifies two distinct risks—split attention and misdirected attention—each undermining comprehension in different ways. The AI Reader Challenge Hyperlinks can both improve and challenge Natural Language Processing (NLP) parsing in large technical documents by providing additional context and structure while also introducing noise and formatting complexities. For modern Large Language Models (LLMs), hyperlinks can be invaluable resources to enhance the quality of text-based applications like Retrieval-Augmented Generation (RAG). AI tools such as FDA’s Elsa approach links differently. Machines do not skim, infer, or guess. They parse hierarchies and rely on structure. A vague cross-reference like “see above” or “refer to Appendix 1” leaves a machine with no anchor point. For AI:
The anchor text of a hyperlink—the clickable words—often provides a concise, semantically meaningful summary of the linked content. An NLP model can use this information to better understand the linked document’s topic and relevance. Internal links that connect different sections of the same document can act as a roadmap, informing NLP models of the document’s structure, similar to how a table of contents functions. But not all anchor text is descriptive. Hyperlinks with generic text like “refer to Section 6.4.2” or “see Appendix 1” introduce noise for NLP systems, as they provide no semantic information. Another factor is technical documents in various formats, such as PDFs or legacy file types, may lack consistently marked- up hyperlinks—posing a major challenge for accurate hyperlink extraction. Without consistent structure and metadata, AI parsing has constrained value. Tools may mis-index or mis-categorize evidence, leading to gaps in automated review or flawed analytics. The Dual Design Challenge The challenge for regulatory writers is designing links that serve two audiences at once. Human-centered design:
These principles are complementary, not competing. Links designed well reduce cognitive load for people and improve interpretability for machines. Why This Matters Now Two shifts make link design urgent:
the regulatory argument weakens. Design Principles Going Forward
Future-ready regulatory documents must support two modes of reading: fast, context-seeking human review and precise, structure-dependent AI parsing. Writers who treat links as part of information design—not just formatting—reduce cognitive load for reviewers today and build trust with AI systems tomorrow. The real question is not whether your documents contain links. The real question is: Are your links designed for humans and machine? https://www.linkedin.com/pulse/designing-document-links-humans-machines-getting-right-gregory- cuppan-veeec Readability determines whether your document works—or fails—in practice. A protocol, briefing book,
or other regulatory submission document may be perfectly accurate, but if readers struggle to navigate the document, they most likely waste time, may make mistakes, and likely lose confidence in the work. Working definition: readability is the degree to which a document enables the intended readers to quickly find, understand, and apply the information with minimal cognitive effort. In regulatory submission documents and protocols, readability is not optional—it is risk mitigation. High readability:
what’s understood becomes dangerous. The Hidden Cost of Poor Readability Poorly designed documents:
hardest to fix. Readability in technical and regulatory documents is not a cosmetic feature—it is a competitive advantage. As Saul Carliner observed, this is the 2nd level of information design: enabling documents to perform reliably in real-world use. He also suggests that when your documents reduce cognitive strain, you build trust with readers. The most successful submission documents I’ve reviewed are not only scientifically rigorous, they are designed to be read. The Writer’s Responsibility Patricia Wright stresses the author’s role in designing readable documents: “The message is that the onus for achieving successful communication cannot be safely left to the reader. Writers need to see themselves as catalysts for the strategies that their readers adopt; and they need to be aware of the design features that promote the selection of particular strategies.” Wright’s insight shifts accountability squarely onto the author’s shoulders. Too often, medical and regulatory writers assume that expert readers will “figure it out” even if a passage is dense or disorganized. That assumption is dangerous in regulatory contexts, where readers work under time constraints, juggle multiple documents, and must reach reliable conclusions. Readable writing is not about lowering standards—it is about following document design standards as an act of responsibility. Authors shape the strategies readers use and they create conditions that promote consistent, accurate, and rapid comprehension. Hyperlinks are everywhere—in protocols, briefing books, submission documents, SOPs, policy manuals, and training guides. Their siren song promises speed, efficiency, and instant navigation.
In Greek mythology, the Sirens’ enchanting melodies lured sailors off course and onto rocky shores. Hyperlinks can work the same way: they invite you to click, to leave the safe harbor of your main discussion or argument in search of something interesting, only to risk losing your place, your context, and sometimes the point entirely. In clinical research protocols, they may link eligibility criteria to lab thresholds, dosing schedules to product handling instructions, or definitions to appendices. For AI and other automated tools, these links are gold: they can map relationships between sections, create a machine-readable network of content, and cross-check for consistency. For human readers, however, hyperlinks come with a trade-off: every link is a micro-decision. When you see a hyperlink, your brain has to ask:
In operational documents like clinical trial protocols, GxP SOPs, or emergency response manuals, these interruptions are more than an inconvenience. They can delay decisions, increase errors, and erode compliance. In regulatory briefing books and Module 2 documents, hyperlink interruptions can undermine both efficiency and precision. Each click risks pulling reviewers away from the main argument, breaking the logical chain that supports a decision. Re-orienting after navigating to annexes, study reports, or external references slows the evaluation process and can erode the clarity of your case. Strategic hyperlinking should serve the narrative—pointing to critical evidence only when it truly strengthens comprehension—rather than scattering attention across disconnected content. Another trap in protocol and submission writing is embedding full source links directly into the main narrative, as if the link itself proves transparency or credibility. In practice, this type of linkage clutters the discussion, distracts the reader, and breaks the flow. Demonstrating a link to source is essential—but the primary text should focus on instruction, reasoning, interpretation, or conclusion. Make the appearance of secondary and tertiary links as subordinate as their intention. Use super script notation to link to footnotes, references, or appendices. The goal is to make these supportive connections accessible without becoming visual speed bumps for your reader. Like the sailors of myth, regulatory and medical writers must recognize when the Sirens are singing. Hyperlinks can be useful guides, but if they tempt the reader away from the main course of the discussion or argument, the hyperlink risks wrecking clarity on the rocky shores of distraction. The safest passage is not to silence the Sirens, but to decide when their song strengthens the voyage—and when it should be left unheard. Why the “Do” Must Precede the Draft in Regulatory Writing
Why do regulatory teams treat Draft 1 like a mirror—something to react to—rather than a blueprint for strategic thinking? Because reacting feels easier than planning. But that shortcut costs time, clarity, and purpose. It’s easier to critique a sentence than to commit to a message. Yet regulatory writing demands something more deliberate: the “do.” The “do” is the document’s core function—what you want the regulatory reader to understand, agree with, or act on. If that function isn’t clear, you’re not writing strategically. You’re just filling pages. When Draft 1 drives the thinking, documents lose purpose—and teams lose time. Real thinking often begins only after Draft 1 is written. By then, the window for deliberate planning has already narrowed. I raised this point with my consulting partner, Stephen Bernhardt. We discussed creating a heuristic tool to guide early drafting. I pushed back: “That assumes teams are willing to think hard before they write.” In my experience, they are not. Most treat Draft 1 as the start of thinking—not the result of it. Medical writers routinely build shells—basic outlines mistakenly called “prototypes” (a separate issue I’ll explore in a future article). These pseudo-prototypes often get ignored. Why?
consequences for silence. The path of least resistance is to do nothing: “I’ll wait for the full draft.” Many teams also delay message planning until the full data set is locked. But by then, it's too late to shape the narrative—only to react to it. Another problem, if leadership doesn’t engage, neither will the rest of the team. Reviewers take their cue from the top. The real issue? Teams skip the pre-draft choices that matter most: defining the document’s purpose, aligning on its message, and designing its logic. Teams avoid thinking about information design—the deliberate structuring of content to make key messages discoverable, logically sequenced, and aligned with the reader’s task. Instead of planning, teams treat the first draft as a mirror—using it to react rather than to think. The Problem: Drafting Replaces Thinking When Draft 1 stands in for strategy, documents suffer. People drop into surface-level edits. They tweak sentences, debate word choices, and micromanage formatting—without questioning the logic beneath it. Few ask: Should this section be saying these things in this way? Fewer still ask: What is this section supposed to do for the regulatory reader? Most cannot answer those questions. I know—because it’s the first thing I ask in every workshop I run. In this dynamic, writing becomes the trigger for strategy, rather than the output of it. When teams treat the draft as a heuristic for meaning, it signals deeper problems:
start rearranging deck chairs on the Titanic—refining detail while ignoring structural failure. A Better Way Forward The fix is simple—but not easy: stop letting Draft 1 lead the thinking. Instead:
Closing Thought When documents are drafted before critical thinking is complete, teams end up managing words—rather than shaping arguments. Regulatory reviewers can feel the difference. I know this from years of feedback and firsthand conversations. Before writing a single sentence, ask:
Writing without purpose isn’t progress. It’s risk. Drug development regulatory submission documents are among the most structured documents in existence—and yet they are often developed in the most chaotic way. As I mentioned in my previous article, teams wait too long to think, treating Draft 1 as the beginning rather than the outcome of deliberate information design planning. Instead of aligning early on logic, purpose, and reader needs, teams begin reacting to prose—often in the form of a partial draft or outline labeled as a “prototype.”. The result? Wasted cycles, misaligned arguments, poor document flow, and late-stage rework that drains time and undermines confidence—especially in mission-critical documents like Clinical Study Reports and the eCTD Module 2.5 Clinical Overview. I suggested in my previous article that development teams need to reconsider what they are generating as document prototypes. Most teams mistake an outline for a prototype. But there’s a key difference:
the establishment of the intellectual architecture of the document. The “So what?” and the “Why?” that are at the core of evaluating, justifying, and arguing. This is the foundation of regulatory writing. After all, the purpose of a submission is not to describe—it is to evaluate, justify, and argue. Those three writing actions sit at the heart of how health authorities assess benefit–risk. From “Primitive Forms” to Design Thinking The word prototype comes from the Greek prototypon—meaning “primitive form” or “original model.” Historically, the concept of building rough models or mock-ups has existed for centuries. However, it was not until the late 1960s that prototyping emerged as a recognized approach in document information design. In software, prototyping gained traction in the early 1970s as an explicit strategy to manage evolving requirements. Winston Royce—often miscredited with creating the Waterfall model—emphasized the importance of incorporating prototyping within code writing to reduce risk. By the 1990s, “document prototyping” became mainstream in many industries that demanded logic and tracebility. Prototyping is not about language and shell tables. It is about early validation of logic, flow, and alignment. A concept that is either poorly understood or undervalued in many Pharma houses. Prototyping as Structured Thinking A real prototype is not a template filled in with placeholder XX, Y% and p-value of 00.0X. A prototype is the framework for judgment. A prototype helps teams clarify what each section must do—not just what it must include. One powerful tool to use is a prototype planning matrix, which breaks down each section into five core elements:  This is the logic scaffold that the decision-making regulatory readers are looking for. Let's walk through an example:  Keep in mind the “So what?” The message is not a study endpoint. The message is a decision in sentence form. The data supports that decision, but the message must guide how the data is presented and evaluated. Teams tell me all the time, “it is all about the data.” I get it. It is indeed about the data. So, during prototyping is the time to make the data needs visible. Where do you need a table, figure, or reference? Too many teams wait until late in the document lifecycle to consider what tables or figures will help carry their argument in a Clinical Overview. Writing Actions and Functional Thinking In my approach, each part of the prototype needs an associated thinking task. What does this section “do” for the reader. It is not about the reporting, it is about the doing:
A strong prototype exposes reasoning, not just structure. It shows how the argument flows, where the evidence lands, and whether the logic holds—before prose locks your thinking into place. ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ New Article: Why Regulatory Writers Need to Prototype Smarter In drug development, we create some of the most structured documents in the world—yet they’re often developed in the most chaotic ways. Too many teams treat Draft 1 as the start of thinking, rather than the outcome of it. In my latest article, I explore why regulatory submission documents—especially eCTD Module 2.5—require prototypes that reveal logic, not just structure. I walk through the difference between outlines and prototypes, introduce a five-part heuristic planning tool, and share examples of how to build prototypes that support decision-making for regulatory readers. It’s not about formatting—it’s about function. It’s not about writing early—it’s about thinking early. Read the full article here: https://www.linkedin.com/pulse/why-regulatory-writers-need-prototype-smarter-gregory-cuppan-solmc Let me know how your team approaches document prototyping—and what gets in the way of doing it well. In regulatory writing, fluency is often praised. To a fault, I might add. Documents that “read well” are
seen as polished, professional, and persuasive. But fluency can be deceptive. A troubling phenomenon is increasingly visible across high-stakes submission documents that I can access: writing that is elegant, but logically unsound. The Problem: Elegant Nonsense These are documents—often Clinical Overviews, Briefing and AdComm Books, or 2.7 Summaries—where the language flows, the sentences vary in rhythm and length, and the vocabulary sounds convincing. But when you interrogate the logic underneath, something’s missing. There is no connective reasoning. The claims float. The evidence is absent, circular, or only loosely linked. I call this elegant nonsense—writing that sounds intelligent but lacks logical structure or evidentiary support. Examples of Elegant but Hollow Writing
high-stakes submission documents? Why This Happens
Why It is Dangerous Regulatory readers are trained to look beyond the language. They must detect bias, weigh risk, evaluate strength of evidence, and make yes/no decisions under pressure. When documents rely on polished language to mask weak thinking, reviewers lose confidence—not just in the section, but in the entire argument. This is the affective level of information design, as suggested by Saul Carliner. Carliner noted that when writing feels effusive (demonstrative, lavish) or evasive, then the writing erodes the reader’s trust—not only in what is stated, but in why it is stated that way. In regulatory contexts, that erosion is consequential: it casts doubt on the sponsor’s judgment and forces the reviewer to work harder to separate signal from gloss. Elegant writing that lacks rigor is not just ineffective—it can be misleading. How to Spot and Fix It Interrogate every conclusion – What is this based on? Where’s the data? Is the reasoning clear? Replace vague synthesis with structured logic – Instead of “Taken together,” show how the pieces fit. Simplify to clarify – If the sentence reads like corporate poetry, ask: is it hiding uncertainty? Separate fluency from function – Does this paragraph sound good, or does it do its job? Consider the phrase: “This study is adequate and well-controlled.” The phrase appears routinely in regulatory documents—concise, confident, and aligned with regulatory guidance language. But unless the concepts are substantiated, this sentence is nothing more than elegant shorthand. Why It Sounds Smart It mimics the regulatory lexicon (such as 21 CFR 314.126). It conveys confidence in the study's design. It’s often used to bridge to conclusions about efficacy or labeling claims. Why It May Be Elegant Nonsense If the surrounding text contains no analysis of the “whys” for:
must move from elegance to substance. Another Example: “The Safety Profile Was Manageable” This phrase shows up in nearly every Clinical Overview and Summary of Clinical Safety I read. The phrase suggests confidence, but what does it actually mean? Why It Sounds Smart It’s concise and optimistic. It implies clinical actionability—something prescribers and regulators care about. Why It May Be Elegant Nonsense “Manageable” sidesteps reasoning. The term offers a verdict without evidence. I suggest that without explaining what was managed and how, this phrase is:
informative work. “Manageable” carries a positive emotional valence (“feel good factor”) without conveying analytical substance. It is language designed to reassure, not inform. Bottom Line Polished phrases like “adequate and well-controlled” or “manageable safety profile” only serve the reader when tethered to evidence and logic. Elegant language that obscures complexity—or avoids specifics—undermines trust in the message. In regulatory writing, clarity must be earned. You make a claim, you better prove it. A Better Standard The goal of regulatory writing is not to sound polished. The goal is to communicate rationales for interpretations and decisions—clearly, truthfully, and logically. Regulatory decisions shape public health. Regulatory reviewers must decide under pressure, with limited time. Our job as writers is not just to report and write elegant prose—but to demonstrate thinking on the page. Writing that hides uncertainty or skips reasoning does not just fail the reader. It fails the process.
Also published to LinkedIn July 2, 2025. https://www.linkedin.com/pulse/when-elegant-writing-masks-flawed-thinking-regulatory-gregory- cuppan-qmmrc |
AuthorGregory Cuppan is the Managing Principal of McCulley/Cuppan Inc., a group he co-founded. Mr. Cuppan has spent 30+ years working in the life sciences with 20+ years providing consulting and training services to pharmaceutical and medical device companies and other life science enterprises. 
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