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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.
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.
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.
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.
The rem and millirem are CGS units in widest use among the U.S. public, industry, and government. [4] However, the SI unit the sievert (Sv) is the normal unit outside the United States, and is increasingly encountered within the US in academic, scientific, and engineering environments, and have now virtually replaced the rem. [5]
In August 2007, Abraxis announced it would again undergo a restructuring to separate its "hospital-based products business" from its "proprietary products business" into two public companies; this would involve the merging of Abraxis Oncology and Abraxis Research sub-units to form a new Abraxis Bioscience (Abraxis Bioscience, Inc., Nasdaq: ABII ...
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