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Reciprocal marketing approval

A process where a drug or therapy approved for sale in one country by a recognized authority is then treated as approved for sale in another country, often with a faster review.

Trusted international regulatory authority

A foreign government agency, similar to the U.S. FDA, that is responsible for ensuring the safety and effectiveness of drugs and medical products in its country, and whose review standards are recognized by the U.S.

Covered product

Any drug or biological product (like vaccines or blood products) that falls under the scope of this bill's new approval process.

Immediately life-threatening disease or condition

A disease or condition where the likelihood of death is high unless effective intervention occurs soon, or where the disease progression is likely to result in death within a short period.

Dossier

A comprehensive collection of documents and data, typically submitted by a drug company, that contains all the scientific and administrative information needed for regulatory approval of a medicine.

Post-market studies

Research and monitoring conducted after a drug has been approved and is available to the public, to gather more information about its long-term safety and effectiveness in a broader patient population.