21st Century Cures Act
The FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in
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Biologics
Biosimilars
Biosimilars are a class of pharmaceutical drug products that are similar to a currently licensed FDA biological product. Biosimilars can
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Pharmaceutical Drug Development (Small Molecules / Large Molecules)
In the world of pharmacology and drug development, there are two ways to classify the molecules used, as small and
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Ligand Binding Assays (LBAs)
Ligand binding assays is an analytical procedure commonly used for large molecules, that relies on ligand molecules binding to macromolecule
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Residual DNA Testing | Host Cell DNA Analysis
Residual DNA testing, or host cell DNA analysis, is the examination of products for traces of DNA that have been
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Immunogenicity of Biologics
The US Food and Drug Administration defines biologics as “a wide range of products such as vaccines, blood and blood
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Regulation of Biological Products and Biopharmaceutical Products
Biological products comprise a wide array of products, all of which are regulated in the US by FDA’s CBER (Center
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Biological Purity | Potency Assays
Biological purity and potency assays are procedures used by laboratories studying medicine, pharmacology, or other biological process, to assess or
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FDA recommends Zika virus testing on all donated blood in USA
On August 26, 2016, The US Food and Drug Administration (USFDA) recommended universal Zika virus testing of all donated blood.
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Biomarkers | Disease Detection
Biomarkers, also called biological markers, are measurable indicators of a biological condition. The exact definition is “a characteristic that is
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