The US Food and Drug Administration USFDA regulates biologics Products through it’s Center for Biologics Evaluation and Research or CBER for short.  According to CBER, Biologics comprise a wide range of Biological products that maybe made of sugars, proteins, or nucleic acids or living entities such as cells and tissues. These Biologics come from human, animal, or microorganisms, but they  may be produced by biotechnology methods.  Biologics maybe produced in many different biological products such as vaccines, blood and blood components,  recombinant therapeutic proteins, somatic cells, allergenics, gene therapy, and other tissues.

The US FDA’s CBER Division Regulates Biologics