The FDA (Food and Drug Administration), the regulatory body of the United States, has issued guidance draft on the advance credibility of AI Models used for drug and biological product submissions.

Additionally, the FDA has also issued preliminary guidance on the development and commercialization of medical devices with Artificial Intelligence (AI) throughout the product’s entire lifecycle. These are the first guidelines published by the FDA on the topic of artificial intelligence, developed in response to the exponential growth of its use since 2016.

Artificial Intelligence and the Growth of the Pharmaceutical Market

With the rapidly growing pharmaceutical AI market, it is crucial for regulatory bodies to take proactive measures. The AI market in the pharmaceutical industry was valued at $1.51 billion in 2024 and is expected to reach $16.49 billion by 2034.

Artificial Intelligence can be a powerful tool to generate data on the safety, efficacy, and quality of drugs and biological products, accelerating the development of new solutions for patients.

Ensuring the Credibility of AI Models in Drug Regulation

AI credibility is a key focus for the FDA due to ethical issues and the challenges that Artificial Intelligence can pose for companies.

This preliminary FDA guide aims to ensure that AI models used in pharmaceutical products are reliable and effective.

The context of AI model usage—how it is applied to solve specific issues—is crucial to assess its credibility. Thus, the FDA proposes a risk-based framework to validate AI models and ensure trust in their results, aligning with its approach to analyzing pharmaceutical and biologic products with AI.

Key Considerations for Using AI in Drugs and Biological Product submissions

In its draft guidance, the FDA recommends that companies adopt a risk-based credibility assessment framework, consisting of seven essential steps to ensure the effectiveness of AI models in the sector:

  1. Define the issue of interest
  2. Define the context of use for the AI model
  3. Assess the risk of the AI model
  4. Develop a plan to establish the credibility of the AI model within the context of use
  5. Execute the plan
  6. Document the results of the credibility assessment and discuss deviations
  7. Determine the suitability of the AI model for the context of use

The FDA aims to provide guidance on the use of Artificial Intelligence to ensure the credibility of AI models, thereby promoting safe and effective innovations in the sector.

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