Regulatory Terms Starting With F

Fast Track Designation (Fast Track)

An FDA program designed to facilitate development and expedite review of drugs treating serious conditions and filling unmet medical needs.

FDA Form 483 (Form 483)

A list of inspectional observations issued by FDA investigators at the end of a facility inspection when conditions may violate the FDCA or related acts.

First-in-Human Study (FIH)

The first clinical trial in which an investigational product is administered to human subjects, typically as a Phase 1 study.

Food and Drug Administration (FDA)

The US federal agency responsible for protecting public health by regulating food, drugs, biologics, medical devices, and cosmetics.