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
2026 Commenting Calendar
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry
Schedule detail:
| Event | Start | End |
|---|---|---|
| Comments Submitted to ISPE | 13-March | 13-April |
| ISPE Comment Lead Team Review | 13-April | 24-April |
| ISPE RSC Review | 24-April | 1-May |
| ISPE CEO Review | 4-May | 8-May |
| Health Authority Deadline | 8- May | |
| ISPE Submits Comments | 8- May |