FDA approves changes to iPLEDGE pregnancy test requirements for isotretinoin

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 for acne, according to a press release.
The modifications include those the FDA recommended on Nov. 30, 2023, to streamline the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) — a program aimed at preventing fetal exposure during isotretinoin treatment — while maintaining safety. These changes will go into effect 180 days after approval, which the FDA issued on Feb. 9, according to the








