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 ...

The FDA approved modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy that permit patients to take a pregnancy test outside of a medical setting during and after isotretinoin treatment ...

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 — ...

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 ...

Test for pregnancy in medical setting before starting isotretinoin, then can be done at ho ...

Q: I’m dealing with hormonal acne. What’s the best way to clear it up?. “I’m a big fan of topical probiotics for hormonal acne—they’re a game changer! They calm redness, strengthen the skin barrier ...

Modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy aim to reduce challenges for patients, prescribers 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 ...

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 ...

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 ...