21st Century Cures Act
The FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in
Read moreThe FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in
Read moreBiosimilars are a class of pharmaceutical drug products that are similar to a currently licensed FDA biological product. Biosimilars can
Read moreIn the world of pharmacology and drug development, there are two ways to classify the molecules used, as small and
Read moreLigand binding assays is an analytical procedure commonly used for large molecules, that relies on ligand molecules binding to macromolecule
Read moreResidual DNA testing, or host cell DNA analysis, is the examination of products for traces of DNA that have been
Read moreThe US Food and Drug Administration defines biologics as “a wide range of products such as vaccines, blood and blood
Read moreBiological products comprise a wide array of products, all of which are regulated in the US by FDA’s CBER (Center
Read moreBiological purity and potency assays are procedures used by laboratories studying medicine, pharmacology, or other biological process, to assess or
Read moreOn August 26, 2016, The US Food and Drug Administration (USFDA) recommended universal Zika virus testing of all donated blood.
Read moreBiomarkers, also called biological markers, are measurable indicators of a biological condition. The exact definition is “a characteristic that is
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