Broadly speaking, a drug is any substance that alters a body’s normal functions when absorbed into a living organism. In pharmacology specifically, a drug is a chemical substance that is used to treat, mitigate, cure or diagnose diseases or otherwise utilized to improve mental or physical well-being. Biologics, on the contrary, is a drug, antitoxin or vaccine synthesized from living organisms or their products. These are made use of as a therapeutic, diagnostic or preventive agent.
FDA’s Center for Drug Evaluation and Research (CDER) is the largest of its five centers. It is entrusted with the responsibility for both prescription and over the counter or non-prescription drugs. The objective of this entity is to ensure that drugs marketed in the United States are effective and safe.
Although the center does not test drugs, its office of Testing and Research performs limited research on drug effectiveness, safety and quality. The CDER conducts important public health task by ensuring that effective, safe and reliable drugs are available to enhance the health of people in the country.
In June 2003, FDA transferred some therapeutic biologic products evaluated and regulated by the Center for Biologics Evaluation and Research (CBER) to CDER. CDER, today holds the responsibility that includes premarket review and continuing oversight on all transferred products. On the transferred products, CBER and CDER consult consistently when there is a need. All other biologic products continue to be the responsibility of the CBER.
CDER also handles generic drugs and other products that are not quintessentially medicines. Products such as antiperspirants, sunscreens, fluoride toothpaste and dandruff shampoos are also considered drugs and fall under the purview of CDER.