ABSTRACT
The United States Food and Drug Administration is responsible for assuring the safety and efficacy of all drugs and biologics sold in the United States. The regulatory authority for drugs is contained in the Federal Food, Drug, and Cosmetic Act, and for biologics in the Public Health Service Act. In the case of biologics, the application for licensure is a product license application, whereas drugs require the submission of a new drug application. In addition, biologics require that the manufacturing establishment also be licensed through the submission of an establishment license application. Fibrin sealant is typical of biologics in that it is a complex mixture of proteins, many of which cannot be easily characterized. The availability of sophisticated purification procedures makes it possible to remove all the extraneous proteins from the preparation, but this is not practical and would reduce the production yield and drive up costs. Fibrin sealant might eliminate the need for staples or suture in some situations.
