Center for Drug Evaluation and Research

Additionally, the CDER employs a "safety team" with 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product's labeling.

Its primary objective is to ensure that all prescription and over-the-counter (OTC) medications are safe and effective when used as directed.

Phase I involves testing new drugs on healthy volunteers in small groups to determine the maximum safe dosage.

Phase II trials involve patients with the condition the drug is intended to treat to test for safety and minimal efficacy in a somewhat larger group of people.

Phase III trials involve one to five thousand patients to determine whether the drug is effective in treating the condition it is intended to be used for.

With the rapid advancement of biologically-derived treatments, the FDA has stated that it is working to modernize the process of approval for new drugs.

In 1987, under Commissioner Frank Young, CDER and the Center for Biologics Evaluation and Research (CBER) were split into their present form.

FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research.