FDA Delays iPLEDGE modification implementation until November 15, 2026, to allow additional time to test system updates, ...

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 — ...

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 ...

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 ...

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 months ...

So, in 2005, the FDA began enrolling people in its new iPledge program, which sought to curb the number of people getting pregnant on the drug. Instead, the process ended up leaving some of its female ...

According to the findings of a recent retrospective analysis, pregnancy and pregnancy-related adverse events related to isotretinoin administration have dropped since the initiation of the iPLEDGE ...

The Food and Drug Administration has approved system changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program for isotretinoin products. The system changes will go into effect ...

Please provide your email address to receive an email when new articles are posted on . iPLEDGE requires participating pharmacies to have an identifying number, which jails and prisons do not have.