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Federal Food, Drug, and Cosmetic Act (FFDCA)

The main law that gives the Food and Drug Administration (FDA) the authority to regulate food, drugs, medical devices, and cosmetics in the United States.

Molecularly Targeted Pediatric Cancer Investigation

Studies conducted on children with cancer for drugs that are designed to attack specific genetic or molecular characteristics of cancer cells, rather than broadly targeting all fast-growing cells.

Active Ingredient

The component of a drug that is biologically active and directly responsible for its therapeutic effect.

Standard of Care

A treatment approach or medical practice that is widely accepted and routinely used by health professionals for a particular condition, based on current evidence.

Preclinical Studies

Laboratory studies, often involving cell cultures or animals, conducted before a drug is tested on humans, to assess its safety and potential effectiveness.

Pediatric Study Plan

A detailed plan submitted by a drug developer to the FDA outlining how and when a drug will be studied in children.

Priority Review Voucher