biologics

21st Century Cures Act

The FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in

Biosimilars

Biosimilars are a class of pharmaceutical drug products that are similar to a currently licensed FDA biological product. Biosimilars can

In the world of pharmacology and drug development, there are two ways to classify the molecules used, as small and

Ligand Binding Assays (LBAs)

Ligand binding assays is an analytical procedure commonly used for large molecules, that relies on ligand molecules binding to macromolecule

The US Food and Drug Administration defines biologics as “a wide range of products such as vaccines, blood and blood

Biological products comprise a wide array of products, all of which are regulated in the US by FDA’s CBER (Center