Generative AI: Four ways to help the FDA streamline its workflow

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 is facing several challenges, like the sifting through the 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, generative AI can support streamlining many of the processes associated with the aforementioned activities. In this article, we will explore the potential of generative AI and related technologies in facilitating regulatory submissions, improving both accuracy and efficiency. Generative AI: Four ways to help the FDA streamline its workflow.

Data analysis

One of the robust features of generative AI is its ability to quickly and accurately examine large volumes of different data types. This means that the FDA can utilize such technology to optimize the process of analyzing 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 exerted by its reviewers to manually assess these applications, improving efficiency and several other aspects like better expenditure of human capital.

Additionally, the use of generative AI and related technologies in analyzing large volumes of data could help identify patterns and trends that the human eye could easily miss due to the sheer size of the data. Overall, this ensures that the products that patients and consumers use are safe and effective, leading to better health outcomes.

Data summarization

Generative AI can scan large volumes of data included in the INDs, BLAs, and NDAs to help extract relevant information for the reviewer without going through an extensive number of documents in case of looking for specific information. In other words, using the technology can help FDA reviewers get meaningful summaries of the trial(s) results, helping them make informed decisions. With the help of natural language processing (NLP) and natural language generation (NLG) technologies, the produced outcome would be not only accurate, but also easy to understand. Overall, this facilitates communication between different FDA stakeholders, leading to a better and more productive review process.

Quality assessment

The use of generative AI to assess the quality of regulatory submissions is another area that the technology could offer significant value to the FDA. In this context, the AI could review regulatory submissions and flag inconsistencies, errors, and incomplete information to the reviewer. This translates into meaningful savings in terms of time and effort for FDA teams.

Submission standardization

When generative AI is implemented within various processes in the FDA, it will be able to generate reports about areas where potential inconsistencies in regulatory submissions appear. Such information could help the FDA, in collaboration with other agencies, introduce more policies that strengthen standardization to avoid pitfalls encountered with previous regulatory submissions. This way, reasons to reject applications could be minimized or even avoided, supporting society’s overall health by making life-saving treatments available faster to the masses.

How can Narrativa help you?

Narrativa is a pioneer in generative AI technologies for the Life Sciences industry. Our regulatory submission solutions have been proven to offer users significant value. For example, our patient narrative automation solution has helped our clients’ medical writing teams report meaningful improvement in terms of time and effort expended to produce initial drafts. One area where they highlighted the tremendous value of our solution is in its ability to generate and update drafts within a few minutes. The Leukemia & Lymphoma Society, one of our partners that implements our patient narrative solution, is in the process of submitting AI-produced patient narratives to the FDA. This is the first submission of its kind in history!

Additionally, Narrativa has a wealth of other solutions, like the anonymization and redaction tool for clinical documents and a solution that automates the creation of Tables, Listings, and Figures (TLFs). Information in TLFs is needed to populate many sections of the clinical study report (CSR). When harnessed, our clients reported that our solution has helped them identify potential errors and inconsistencies in their databases that were not previously visible. Also, statistical programmers and other stakeholders have reported notable improvement in initial draft creation, which decreased from weeks to just a few minutes!

Narrativa’s solutions do not stop there. We have an increasing number of solutions that fit the pharmaceutical and biotech industry and involve automating labor-intensive, repetitive tasks, saving time and money, and helping direct human efforts toward more critical projects. Companies approach us to help them empower their teams by automating routine tasks; you can do so, too, by booking a demo session. 

About Narrativa

Narrativa is an internationally recognized B2B content services company that believes people and artificial intelligence are better together. Through its proprietary generative AI content automation platform, teams of all types and sizes are empowered to build and deploy smart composition, business intelligence reporting, and process optimization content solutions for internal and external audiences alike. 

Its tech stack, consisting of data extraction, data analysis, natural language processing (NLP), and natural language generation (NLG) tools, all seamlessly work together to produce content quickly and at scale. In this way, Narrativa supports the growth of businesses across a variety of industries, while also saving them both time and money. Accelerate the potential with Narrativa.

Contact us to learn more about our solutions!