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Luspatercept, sold under the brand name Reblozyl, is a medication used for the treatment of anemia in beta thalassemia and myelodysplastic syndromes. [ 5 ] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication .
All substances must be declared in the material data sheet (MDS) of the IMDS to a resolution of 1 gram or better – not just declarable and prohibited substances (e.g. Cr VI / Hg / Pb / Cd). Substances and materials of products must be known in detail so that it may be delivered by the OEMs to dismantler companies in order to achieve the goals ...
MDS information is transmitted electronically by nursing homes to the MDS database in their respective states. MDS information from the state databases is captured into the national MDS database at Centers for Medicare and Medicaid Services (CMS). Sections of MDS (Minimum Data Set): Identification Information; Hearing, Speech and Vision
An example SDS, including guidance for handling a hazardous substance and information on its composition and properties. A safety data sheet (SDS), [1] material safety data sheet (MSDS), or product safety data sheet (PSDS) is a document that lists information relating to occupational safety and health for the use of various substances and products.
Luspatercept is a TGFβ ligand that acts to decrease SMAD2 and SMAD3 signaling involved in erythropoeisis and may be used in MDS with anemia that is not responsive to erythrocyte stimulating agents or mild MDS with ring sideroblasts. Luspatercept was shown to decrease the need for transfusions and this effect lasted for a median of 30.6 weeks.
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need.
The purpose of any Production Part Approval Process (PPAP) is to: Ensure that a supplier can meet the manufacturability and quality requirements of the parts supplied to the customer; Provide evidence that the customer engineering design record and specification requirements are clearly understood and fulfilled by the supplier
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