The iPLEDGE program is a risk management system mandated by the U.S. Food and Drug Administration to prevent fetal exposure to isotretinoin, a medication used for severe acne that doesn’t ...

The FDA has approved the iPLEDGE program, a modified risk-management program designed to prevent fetal exposure to isotretinoin. The reasons for this enhanced program, and the implications for ...

MDedge News, February 21, 2023 Embattled iPLEDGE Program: Changes Ahead? The FDA announced that two FDA advisory committees will meet in March to discuss proposed changes to the embattled program ...