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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)

Federal Food, Drug, and Cosmetic Act (FD&C Act)

The main law that gives the Food and Drug Administration (FDA) the authority to oversee the safety of food, drugs, medical devices, and cosmetics in the U.S.

Pediatric Study Requirements

Rules that require drug companies to study how their new drugs affect children, including appropriate dosages and potential side effects, to ensure safe and effective use in younger patients.

Orphan Drug

A drug developed to treat a rare disease or condition, which affects a small percentage of the population. These drugs often receive special incentives for development.

Due Diligence

A reasonable level of care and effort that someone is expected to take to meet a requirement or obligation. In this context, it refers to a drug company's good faith efforts to conduct required pediatric studies.

Enforcement Actions (under Section 303)

Steps the FDA can take, such as issuing fines or taking legal action, against companies that violate regulations set forth in the FD&C Act.

Waivers and Deferrals

Exceptions or delays granted by the FDA for drug companies regarding pediatric study requirements, often given when studies are not feasible or necessary for specific reasons.