An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

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 regulatory action related to drugs, devices, or food. Sometimes used by drug manufacturers to raise concerns about competitors' products.

Generic Drug

A medication that is identical in dosage, safety, strength, route of administration, quality, performance characteristics, and intended use to a brand-name drug. They are typically much cheaper than their brand-name counterparts.

Biosimilar Drug

A biologic medical product that is highly similar to an already approved biologic product (called a reference product) and has no clinically meaningful differences in terms of safety, purity, and potency. They are comparable to generics for traditional drugs.

Federal Trade Commission (FTC)

A U.S. government agency whose principal mission is the enforcement of civil antitrust law and the promotion of consumer protection.

Sham Petition

A petition filed with the FDA that is objectively baseless and is submitted not to achieve a favorable outcome, but to use the process itself as a tactic to interfere with a competitor's business, such as delaying the approval of a generic drug.

Covered Application

Specific types of drug applications filed with the FDA, including those for generic drugs (Abbreviated New Drug Applications) and biosimilar products.