Regulatory Writing for Two Audiences: Humans and FDA Algorithms
Every regulatory document now faces two readers: people and AI algorithms.
In January 2025, the FDA released its first guidance "Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products" on the use of artificial intelligence in regulatory decision‑making. Within the same quarter, the agency began using generative tools such as ELSA and exploring cderGPT with OpenAI.
Review is intended to become a parallel exercise: expert panels evaluate scientific content, while language models scan for structure, consistency and traceability.
Traditional authoring often leaves small gaps:
A protocol may switch between “participant” and “subject”.
A clinical study report may restate a primary endpoint in different words.
A CMC section may cite data that sit outside the document.
Human reviewers can reconcile these differences; automated systems highlight them in seconds, extending the question‑and‑answer cycle and potentially introducing delays [to the next milestone].
Medical writing has evolved beyond regulatory compliance; it now must be compatible with AI.
Peer AI enables organizations to write for this new future. Documents drafted in Peer AI are prepared for both forms of scrutiny from the first keystroke – the platform:
Links every statement to its source data for accurate traceability.
Checks terminology across protocols, CSRs and CMC sections.
Guides authors as content moves from table to narrative or vice versa.
Ensures clarity and precision: AI scanning means less room for implied insights
Optimizes document structure and content flow with built-in readability checks
Connects documents to ensure consistency between sections, documents and versions to prevent unintended flags
The FDA guidance emphasizes a transparent chain from raw data to regulatory decision. Submissions that meet this expectation will move more smoothly through a review process now aided by machine intelligence. Those that do not are likely to require additional reconciliation, diverting time and resources from later development stages.
Darwin's insight about survival rings especially true today as we witness the evolution of medical writing from regulatory necessity to a bridge between human ingenuity and AI innovation. The professionals who adapt now won't just participate in the future - they will create it.
Peer AI will continue to share lessons on authoring documents that satisfy both scientific rigor and algorithmic checks. Stay tuned for ongoing insights into building submissions ready for tomorrow’s review.
Email us at hello@getpeer.ai to schedule a personalized demo.