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 ...

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 ...

Please provide your email address to receive an email when new articles are posted on . Pregnancies, abortions and fetal defects associated with isotretinoin exposure continue to be a problem even ...

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 ...

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 ...

(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 ...

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 ...

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 ...

Dermatologists are renewing their concerns that efforts to prevent pregnant women from using a drug that can cause birth defects may also keep the drug from patients who need it for severe acne. The ...

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 ...