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Federal Food, Drug, and Cosmetic Act (FDCA)

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

Molecularly Targeted Pediatric Cancer Investigation

A study required by the FDA to determine the safety and effectiveness of a drug that targets specific biological pathways related to cancer growth in children.

Active Ingredient

The component in a drug that is biologically active and produces the intended effects (e.g., treating a disease).

Biological Product (Biologic)

A type of medicine, often complex, made from living organisms or their products, such as vaccines, blood products, and gene therapies.

Preclinical Studies

Early research on a drug, usually conducted in labs or on animals, before human testing begins, to determine its safety and potential effectiveness.

Initial Pediatric Study Plan (IPSP)

A plan that drug developers submit to the FDA outlining how they intend to study a new drug in children, including proposed studies and timelines.