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# Workshop on AI in Drug/Biologic Development
- URL: https://www.fdaweb.com/workshop-on-ai-in-drug-biologic-development/
- Published: 2024-07-10T12:00:00.000Z
- Updated: 2026-09-14T14:35:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157318

*Federal Register* [notice](https://www.govinfo.gov/content/pkg/FR-2024-07-10/pdf/2024-15125.pdf?ref=fdaweb.com): FDA is announcing an 8/6 public workshop entitled “Artificial Intelligence (AI) in Drug & Biological Product Development” to bring drug developers and AI experts together to discuss guiding principles for the responsible use of AI in developing drugs and biological products. Topics for discussion include:

- Optimizing model design through multidisciplinary expertise. Specifically, stakeholders will explore integrating experts from diverse fields, such as medicine, statistics, pharmacology, data science, and engineering to ensure the development of optimal AI models.
- Exploring strategies for overcoming common data-related challenges (e.g., the availability of fit-for-use data that can be used in drug development. These include data availability and access via federated learning, data quality issues (i.e., representativeness of data, bias, etc.), and the use of synthetic data.
- Balancing model performance, explainability, and transparency of AI models. Additionally, discussants will share strategies for assessing the need to integrate humans into the decision-making process.
- Identifying key gaps and challenges curbing the use of AI in drug and biological product development and exploring potential strategies, collaborations, and initiatives to address these challenges.