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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. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
The fenfluramine REMS requires health care professionals who prescribe fenfluramine and pharmacies that dispense fenfluramine to be specially certified in the fenfluramine REMS and that patients be enrolled in the REMS. As part of the REMS requirements, prescribers and patients must adhere to the required cardiac monitoring with echocardiograms ...
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 (also known as Accutane), [1] a prescription medication used for the treatment of acne. [2] [3] Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE ...
REMS is the first clinically available method for the direct non-ionizing measurement of BMD at the axial sites, which include the femur and lumbar spine. Its portability introduces the advantage ...
Biosimilar. A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. [1] Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original ...
U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine is a pending United States Supreme Court case to challenge the U.S. Food and Drug Administration (FDA)'s approval of mifepristone, a drug frequently used in medical abortion procedures. The plaintiffs, led by the Alliance for Hippocratic Medicine (AHM), argue that the FDA ...
Radiofrequency Echographic Multi Spectrometry applied to lumbar spine. Radiofrequency Echographic Multi Spectrometry (REMS) is a non-ionizing technology for osteoporosis diagnosis and for fracture risk assessment. REMS processes the raw, unfiltered ultrasound signals acquired during an echographic scan of the axial sites, femur and spine.
Rapid eye movement sleep ( REM sleep or REMS) is a unique phase of sleep in mammals (including humans) and birds, characterized by random rapid movement of the eyes, accompanied by low muscle tone throughout the body, and the propensity of the sleeper to dream vividly. The REM phase is also known as paradoxical sleep ( PS) and sometimes ...