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 . iPLEDGE requires participating pharmacies to have an identifying number, which jails and prisons do not have.

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 ...

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 ...

More than a month after the launch of the new iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program, the operation still isn't running smoothly for many dermatologists, pharmacists, and ...

Jessica Soohoo, a 20-year-old student in New Jersey, was supposed to start her sixth and final month of isotretinoin acne treatment in December. Isotretinoin is the generic name for Absorica, Claravis ...

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 ...

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 ...

The US Food and Drug Administration (FDA) is convening an emergency meeting today with representatives from the American Academy of Dermatology Association (AADA) to discuss the flawed rollout of the ...

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 ...