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The iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) intended to manage the risk of birth defects caused by isotretinoin, ...
When the iPledge system was implemented in 2006, it introduced additional digital requirements for the patient and provider. Among the most recent changes to the iPledge site is the incorporation ...
Isotretinoin, also known as 13-cis-retinoic acid and sold under the brand name Accutane among others, is a medication used to treat skin diseases like harlequin-type ichthyosis, and lamellar ichthyosis, and severe cystic acne or moderate acne that is unresponsive to antibiotics. [6]
[103] iPledge requires the woman to have two negative pregnancy tests and to use two types of birth control for at least one month before isotretinoin therapy begins and one month afterward. [103] The effectiveness of the iPledge program is controversial due to continued instances of contraception nonadherence. [103] [104]
Patients who become lost to follow-up during a clinical research trial result in many negative effects on the outcome of the trial and on the pharmaceutical company sponsoring the clinical research trial. [2]
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Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...