Regulatory Commenting Calendar

ISPE’s commenting process is overseen by ISPE’s Regulatory Steering Council (RSC). The Regulatory Quality Harmonization Committee welcomes inquiries from ISPE members or groups who wish to comment on a document through ISPE. 

• The Regulatory Quality Harmonization Committee determines whether the document falls within the scope of ISPE commentary
• A team of subject matter experts are convened to lead the comment development
• Final comments are vetted by ISPE regulatory leadership prior to submission
• For questions on any of the commenting projects below, please contact regulatorycomments@ispe.org

2025 Commenting Calendar

Considerations for Complying with 21 CFR 211.110 FDA-2024-D-5374

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FDA Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations  FDA-2024-D-4488

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Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products  FDA-2024-D-4689

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ICH M15 – General Principles for Model-Informed Drug Development (MID)

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