> ## 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.

# Support, Suggestions for FDA Regulatory AI Guidance
- URL: https://www.fdaweb.com/support-suggestions-for-fda-regulatory-ai-guidance/
- Published: 2025-04-09T12:00:00.000Z
- Updated: 2026-09-14T14:57:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158977

Responding to an FDA draft guidance on considerations for using artificial intelligence (AI) to support regulatory decision-making for drug and biological products, Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the agency’s efforts with the draft. The association’s 4/7 [comment letter](https://downloads.regulations.gov/FDA-2024-D-4689-0090/attachment%5F1.pdf?ref=fdaweb.com) lays out its views in these major sections:

- AI will play an increasingly important role in developing innovative medicines for patients, and the draft guidance is an important step toward providing clear FDA expectations on how AI can be used to support regulatory decision-making;
- PhRMA supports the agency’s efforts to provide guidance that applies to a broad range of AI use cases and urges FDA to clarify the scope of its regulatory authority;
- clearer definitions for key terms could reduce ambiguity and ensure broader understanding among stakeholders;
- PhRMA considerations for the guidance’s credibility framework;
- PhRMA encourages FDA to provide additional specificity on expectations for the lifecycle maintenance of AI models;
- PhRMA encourages FDA to establish clear engagement options that increase certainty for sponsors;
- PhRMA urges the agency to address the challenges associated with using third-party technologies and foundation models; and
- harmonization among global health authorities is key to fostering innovation.

In its [response](https://downloads.regulations.gov/FDA-2024-D-4689-0101/attachment%5F1.pdf?ref=fdaweb.com), the Duke-Margolis Institute for Health Policy says the guidance was well received by academic and practicing communities and the clinical and manufacturing-based use studies were particularly helpful to illustrate the guidance’s concepts. The institute asks for further information on clarification of risk types, labeling guidance about the use of AI in product development, and tool development disclosure considerations.