The iPLEDGE program is a risk evaluation and mitigation strategy (REMS). The Food and Drug Administration (FDA) may require a REMS to help ensure that a medication’s benefits outweigh its risks. A ...

Please provide your email address to receive an email when new articles are posted on . The AAD and the FDA recommended changes to the iPledge system, but none have yet taken place. The AAD’s iPledge ...

March 9, 2006 (San Francisco) — The largest and arguably most complex risk-management program ever undertaken by the US Food and Drug Administration is sparking a commensurate measure of controversy — ...

In December 2021, major changes took effect in the iPLEDGE program, the US Food and Drug Administration (FDA)–required safety program for managing the risks of isotretinoin's teratogenicity and ...

An FDA advisory committee on Wednesday voted 17-4 (with one abstention) to recommend removing a "lockout period" from a risk evaluation and mitigation strategy (REMS) for isotretinoin prescribing that ...

Please provide your email address to receive an email when new articles are posted on . The FDA has issued a notification to isotretinoin manufacturers to modify the iPledge Risk Evaluation and ...

In a nod toward transgender inclusiveness, the FDA revised the iPLEDGE risk-modification program for isotretinoin by rewording the reproductive categories for patients. Beginning December 13, patients ...

The Food and Drug Administration has approved system changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program for isotretinoin products. The system changes will go into effect ...

It was determined that these changes would help reduce the burden on patients and providers while ensuring the benefits of isotretinoin treatment continue to outweigh the risks of embryo-fetal ...

WASHINGTON The Food and Drug Administration announced that Covance, the developer of the iPLEDGE risk management program has fully implemented the program revisions approved by the FDA on Oct. 3. The ...

More than 120 pregnancies were exposed to a birth defect-causing agent during the first year of iPledge, a mandatory program designed to prevent pregnant women from being exposed to the anti-acne ...