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Citizen Petition

A formal request submitted to the Food and Drug Administration (FDA) by an individual or organization, asking the agency to take or refrain from taking specific administrative actions, such as approving or delaying a drug approval.

Generic Drug

A medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Generic drugs are typically much cheaper than their brand-name counterparts.

Biosimilar

A biological product that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved reference biological product. Like generics, biosimilars offer lower-cost alternatives to expensive brand-name biologics.

Federal Food, Drug, and Cosmetic Act

The main federal law that gives the FDA authority to oversee the safety of food, drugs, medical devices, and cosmetics. This bill amends a specific section of this act.

Civil Action

A lawsuit brought to enforce, redress, or protect private rights. In this context, it refers to a lawsuit filed against the FDA regarding a drug approval.

Dismiss Without Prejudice

A court ruling that ends a lawsuit but allows the plaintiff (the person who filed the suit) to refile the same case later, usually after correcting an error or meeting a prerequisite.