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FDA Mandates Isotretinoin Manufacturers to Update iPLEDGE Safety Program, Eases Pregnancy Testing Po

Thursday, December 28, 2023   (0 Comments)
Posted by: Kim Coghill

The FDA recently announced that it has notified isotretinoin manufacturers that they must update the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS), a safety program to minimize the risk posed by the drug to fetal development.


The changes are intended by the FDA to "minimize burden on patients, pharmacies, and prescribers while maintaining the safe use of isotretinoin."


These requirements include allowing increased flexibility on the policies governing pregnancy testing for patients who are prescribed isotretinoin. You can find more information on this change here.


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