> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# BIO Supports FDA’s AI/ML Discussion
- URL: https://www.fdaweb.com/bio-supports-fdas-ai-ml-discussion/
- Published: 2023-08-08T12:00:00.000Z
- Updated: 2026-09-14T18:48:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155048

The Biotechnology Innovation Organization (BIO) says it “applauds FDA for the issuance of a comprehensive and clear discussion paper on the use of artificial intelligence/machine learning (AI/ML) in drug development and supports FDA’s risk-based approach to the review, assessment, and regulation.” In a comment [letter](https://downloads.regulations.gov/FDA-2023-N-0743-0021/attachment%5F1.pdf?ref=fdaweb.com), BIO says it also welcomes the agency’s decision to build on existing guidance and regulatory tools for using AI in drug development.

“As the agency continues to gain experience in this space,” the letter says, “BIO notes that this discussion document is a good first step and more insights on different algorithms or statistical methods supporting various aspects of drug development, such as signal detection and risk assessment, would be useful.”

BIO says it generally supports the National Institute of Standards and Technology in the AI/ML space since it is a cross-sector topic and the overarching high-level principles and standards should apply to all sectors, including drug development. “All parts of the federal government should be aligned in this space,” it says. “With AI/ML being a dynamic and nascent field, BIO supports an incremental approach to guidance development that would allow for sufficient learning opportunities from both sponsors and FDA.”

The letter also responds to FDA’s request for input on specific questions.