FDA Postpones Opioids Advisory Committee Meeting and Cancels Kidney Drug Review

The FDA has postponed a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee, originally scheduled for February 5, 202538.

This postponed meeting was set to discuss postmarketing requirements for extended-release/long-acting opioids3.

Another FDA advisory committee meeting, scheduled for February 24, 2025, to review a kidney drug has been canceled12.

The canceled meeting was for the Cardiovascular and Renal Drugs Advisory Committee to discuss a supplemental new drug application for FABHALTA (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G)29.

These changes to the FDA's advisory committee schedule come amid ongoing confusion and uncertainty1.

Other FDA advisory committee meetings, such as the General and Plastic Surgery Devices Panel meeting on February 20, 2025, are still scheduled to proceed as planned510.

Sources:

1. https://endpts.com/two-february-fda-adcomm-meetings-are-delayed-canceled/

2. https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-24-2025-meeting-cardiovascular-and-renal-drugs-advisory-committee-02242025

3. https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-opioids-adcomm-postponed-are-communications-freeze-travel-ban-to-blame-H4WQ4DLAJBD5HOZAWBCSRDBTIA/

5. https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-20-2025-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee

8. https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-5-2025-joint-meeting-drug-safety-and-risk-management-advisory-committee-and-anesthetic-and

9. https://www.fda.gov/advisory-committees/cardiovascular-and-renal-drugs-advisory-committee/2025-meeting-materials-cardiovascular-and-renal-drugs-advisory-committee

10. https://www.fda.gov/advisory-committees/advisory-committee-calendar