Many medicines are biologics. It means, that they are obtained from living sources, for example, Cells. Biologics are complex mixtures, molecules of active components of which (usually proteins), hundreds of times larger than the molecules of most traditional drugs. Usually, such drugs are effective only when administered intravenously. Biologics include blood and its components, vaccines, as well as recombinant proteins and monoclonal antibodies obtained using biotechnological methods. Most biologics are subject to the jurisdiction of the FDA, regulated by the Public Health Services Act and requires a biologic license prior to being marketed (biologic license application, BLA).
In the pharmaceutical market, the FDA regulates prescription drugs in the US: clinical trials FDA approval of new drug collection of information on side effects FDA approval does not allow the sale of drugs without a prescription (OTS). At the same time, the ingredients for the FDA are undergoing the approval process for a new drug in the FDA..