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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.
Once a doctor decides a patient is a candidate for isotretinoin, [10] they counsel the patient to ensure they understand the drug and the potential side effects. Once the patient signs the necessary paperwork, their doctor will give them a patient ID number, ID card, and program educational materials.
In 2018, Celgene was at the top of a list of companies that the FDA identified as refusing to release samples to competitors to create generics. [53] Generic manufacturer Lannett Company initiated antitrust litigation that accused Celgene of using its REMS for THALOMID (thalidomide) to violate the anti-monopolization provisions of the Sherman ...
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. The analysis is performed in the frequency domain.
Abraxis BioScience was a global biopharmaceutical, and nano-medicine company that developed treatments for critically ill patients. It had over 2000 employees worldwide in 2007. [3]
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Rems or REMS may refer to: Radiofrequency Echographic Multi Spectrometry; Rams (card game), a card game also known as Rems; Rapid eye movement sleep, a sleep phase; Rems (river), a river in Germany; Research, Evaluation, Measurement, and Statistics, a concentration in Educational Psychology at Texas Tech University
The Radiological Response and Emergency Management System (RREMS) is a system managed by the Department for Energy Security and Net Zero and used by the Government of the United Kingdom [1] which records and analyses the level of radioactivity across the United Kingdom.