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 — ...

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 ...

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 . Researchers, along with the American Academy of Dermatology, have organized an iPLEDGE Workgroup to advocate for ...

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 ...

(TNS) -- It has been 13 years since the U.S. Food and Drug Administration took a bold step to prevent birth defects caused by the only drug that can cure severe acne. Women were still getting pregnant ...