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Federal Food, Drug, and Cosmetic Act

The main federal law that gives the Food and Drug Administration (FDA) the authority to oversee the safety of food, drugs, medical devices, and cosmetics in the United States.

Wholesale Distributor

A company that buys large quantities of drugs directly from manufacturers and then sells them to pharmacies, hospitals, and other healthcare providers.

Mutual Recognition Agreements

Formal agreements between the U.S. Food and Drug Administration (FDA) and foreign regulatory bodies (like those in the UK or EU) to accept each other's inspection results for certain products, avoiding duplicate inspections.

Organisation for Economic Co-operation and Development (OECD)

A group of 38 member countries that work together to promote economic growth, prosperity, and sustainable development, often used for comparing economic and social data.

Active Ingredient

The part of a drug that produces its intended effect on the body, making it work for a specific health condition.

Biosimilar

A biological product that is highly similar to an existing FDA-approved biological product (called the reference product) and has no clinically meaningful differences in terms of safety, purity, and potency.