Please provide your email address to receive an email when new articles are posted on . The FDA has issued a notification to isotretinoin manufacturers to modify the iPledge Risk Evaluation and ...
With clinician approval, reproductive-age patients prescribed isotretinoin-containing drugs for acne may complete required pregnancy testing at home or in other non-medical settings, the FDA announced ...
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Making sense of iPLEDGE REMS changes
The FDA has updated the iPLEDGE REMS program for isotretinoin to reduce burdens on patients, prescribers, and pharmacies while maintaining safety measures. New rules allow more flexibility in ...
The FDA has approved long-awaited changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to minimize the burden on patients, prescribers, and pharmacies while protecting safe use of the ...
It was determined that these changes would help reduce the burden on patients and providers while ensuring the benefits of isotretinoin treatment continue to outweigh the risks of embryo-fetal ...
Industry and patient groups are asking the US Food and Drug Administration (FDA) to take a flexible approach when reviewing changes that come with switching third-party vendors that provide services ...
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