The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective. The Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs (OTC).  CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotion activities; review, monitoring, and enforcemen