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.

Despite vigorous protests from the American Academy of Dermatology (AAD), the iPledge program, an online restricted-distribution program for prescribing the acne drug isotretinoin (Accutane ...

The iPLEDGE program is a risk management system mandated by the U.S. Food and Drug Administration to prevent fetal exposure to isotretinoin, a medication used for severe acne that doesn’t ...

The FDA has approved the iPLEDGE program, a modified risk-management program designed to prevent fetal exposure to isotretinoin. The reasons for this enhanced program, and the implications for ...

The iPledge program is aimed at preventing fetal exposure to isotretinoin. It includes a centralized system used by physicians, pharmacists and patients. For years, the American Academy of ...

Dermatologists have complained that the U.S. Food and Drug Administration's iPledge program is delaying treatment for patients who require the drug Accutane. The program, which was adapted six ...

Since the 1980s, the FDA has tried to address isotretinoin’s risks, eventually landing on the iPledge program, a risk evaluation and mitigation strategy (REMS) whose goal is to ensure 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 ...

The reproductive rights controversy nobody’s talking about In our current political climate, the iPledge program hits differently. Some patients feel like they’re trading their reproductive ...

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 iPLEDGE program is a Risk Evaluation and Mitigation Strategy (REMS) that aims to reduce fetal exposure to isotretinoin, a highly teratogenic disease-modifying agent used for the treatment of ...

The iPledge program to register women of childbearing age who use the drug Accutane and its generic versions — requiring them to have pregnancy tests before getting a prescription — is ...