Regulatory Commenting Calendar

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

  • The Regulatory Steering Council (RSC) 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

FDA Draft Guidance for Industry and Food and Drug Administration Staff: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations  FDA-2024-D-4488

EventStartEnd
Call for comments Period1 Jan 2025 10 Mar 2025 
Comments to comment lead team10 Mar 202510 Mar 2025
Comment lead team review10 Mar 202521 Mar 2025
Final Review24 Mar 202528 Mar 2025
Team sends to CEO31 Mar 202531 Mar 2025
CEO Review31 Mar 20254 Apr 2025
FDA Deadline 7 Apr 2025

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FDA Draft Guidance for Industry and Other Interested Parties: Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products  FDA-2024-D-4689

EventStartEnd
Call for comments Period1 Jan 2025 3 Mar 2025 
Comments to comment lead team3 Mar 20253 Mar 2025
Comment lead team review3 Mar 202514 Mar 2025
Final Review17 Mar 202521 Mar 2025
Team sends to CEO24 Mar 202524 Mar 2025
CEO Review24 Mar 202528 Mar 2025
ISPE Internal Deadline 31 Mar 2025
FDA Deadline 7 Apr 2025

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EMA: Guideline on the quality aspects of mRNA vaccines

EventStartEnd
Call for comments Period7_ April25-Aug
Comments to comment lead team 25- Aug
Comment lead team review25-Aug5-Sept
Final Review8-Sept18-Sept
Team sends to CEO 22-Sept
CEO Review22-Sept26-Sept
Agency Deadline 20-Sept

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