The Food and Drug Administration (FDA) upholds public health and well-being by ensuring the safety and efficacy of medications, biologics, and medical devices. To achieve this objective, the FDA utilizes rigorous and complex evaluation techniques that ensure usable and safe products are available to consumers. Currently, the FDA faces several challenges, including sifting through an ever-increasing number of applications submitted for evaluation, the complexity of clinical studies, and the need for more efficient and accurate evaluation techniques.

As a subset of artificial intelligence, agentic AI can help streamline many of the processes associated with these activities. In this article, we explore the potential of agentic AI and related technologies in facilitating regulatory submissions while improving accuracy and efficiency.

Data analysis

One of the robust features of agentic AI is its ability to quickly and accurately examine large volumes of diverse data types. This allows the FDA to optimize the analysis of regulatory submissions such as New Drug Applications (NDAs), Biologics License Applications (BLAs), and Investigational New Drug (IND) applications. With this technology, the FDA can significantly reduce the time and effort required for manual review, improving efficiency and optimizing the use of human capital.

Additionally, agentic AI and related technologies can help identify patterns and trends that may be overlooked due to the sheer volume of data. This supports safer and more effective products reaching patients and consumers, ultimately contributing to better health outcomes.

Data summarization

Agentic AI can scan large volumes of data included in INDs, BLAs, and NDAs to extract relevant information without requiring reviewers to manually navigate extensive documentation. In other words, the technology can help FDA reviewers obtain meaningful summaries of clinical trial results, supporting informed decision-making.

With the support of natural language processing (NLP) and natural language generation (NLG), the resulting outputs are accurate and easy to interpret. This enhances communication among FDA stakeholders and contributes to a more productive review process.

Quality assessment

Using agentic AI to assess the quality of regulatory submissions is another high-value application. The technology can review submissions and flag inconsistencies, errors, and incomplete information for reviewers. This translates into meaningful time and effort savings for FDA teams.

Submission standardization

When agentic AI is integrated into FDA processes, it can generate reports identifying areas of inconsistency in regulatory submissions. These insights can support the development of stronger standardization policies in collaboration with other agencies. As a result, application rejections due to formatting or documentation issues may be reduced, helping life-saving treatments reach patients more quickly.

How can Narrativa help you?

Narrativa is a pioneer in agentic AI technologies for the life sciences industry. Our regulatory submission solutions have consistently delivered measurable value. For example, our patient narrative automation solution has enabled medical writing teams to significantly reduce the time required to generate initial drafts. Clients report that drafts can now be generated and updated within minutes.

The Leukemia & Lymphoma Society, one of our partners, is in the process of submitting AI-produced patient narratives to the FDA, marking the first submission of its kind.

Narrativa also offers additional solutions, including an anonymization and redaction tool for clinical documentation and automation for Tables, Listings, and Figures (TLFs). TLF data populate key sections of the clinical study report (CSR). Clients report that our solutions help identify previously undetected database inconsistencies while reducing draft creation timelines from weeks to minutes.

Our expanding portfolio of solutions for pharmaceutical and biotech companies focuses on automating labor-intensive tasks, reducing costs, and enabling teams to focus on higher-value initiatives. Organizations partner with us to empower their teams through automation. You can do the same by booking a demo session.