Conventionally, a drug refers to a synthesized pharmaceutical molecule or compound intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The pharmaceutical industry uses the term small molecule drug to refer to this type of therapy.
In the broader U.S. Food and Drug Administration (FDA) definition, drugs are any substance (other than food) intended to affect the structure or any function of the body. Biologics are included within this broader definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process). The Center for Drug Evaluation and Research (CDER) regulates drugs, including some biologics. Biologics regulate by CDER include monoclonal antibodies, therapeutic proteins, and immunomodulators. The Center for Biologics Evaluation and Research (CBER) is the Center within the U.S. Food and Drug Administration (FDA) that regulates the remaining biologics, including cellular products, gene therapy, vaccines, allergenic extracts, antitoxins, antivenins, venoms, blood, blood components, and plasma derived products
U.S. Food and Drug Administration (FDA): Drugs@U.S. Food and Drug Administration (FDA) Glossary of Terms
U.S. Food and Drug Administration (FDA): Transfer of Therapeutic Products to the Center for Drug Evaluation and Research (CDER)
NCATS Toolkit for Patient-Focused Therapy Development: Discovery of Therapeutic Approach