Drugs

A drug is legally defined in the United States as (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).^[1]

Center for Drug Evaluation and Research (CDER)

The Center for Drug Evaluation and Research (CDER), a department within the US Food and Drug Administration’s Office of Medical Products and Tobacco, is responsible for the safety and efficacy of drugs in the US. As part of the FDA, CDER regulates both over-the-counter and prescription drugs, including biological therapeutics and generic drugs. Their oversight extends beyond traditional pharmaceuticals, including over-the-counter health and hygiene products such as fluoride toothpaste, anti-perspirants, dandruff shampoo, and sunscreens.^[2] CDER acts as a consumer watchdog within the context of the healthcare system, ensuring the evaluation of new drugs before they enter the market. The organization reviews new drug applications, provides both doctors and patients with information they need on how to use the drugs correctly, and ensures that brand name and generic drugs work correctly and the benefits of the drug outweigh any risks. CDER oversees the research, development, manufacturing, and marketing of drugs. They monitor advertising for prescription drugs and stay abreast of any unexpected risks detected after drug approval—so that drug labels can be revised or products can be taken off the market.^[3]