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The primary set of laws giving authority to the FDA to oversee the safety of food, drugs, and cosmetics.

A mechanism to facilitate the availability and use of medical countermeasures, including drugs and vaccines, during public health emergencies.

A law that provides incentives for drug companies to develop treatments for rare diseases affecting fewer than 200,000 people in the United States.

A recall issued by the FDA for products that are unlikely to cause adverse health consequences but have violated FDA regulations.

The division of the FDA responsible for ensuring that drugs are safe and effective.

The formal proposal for a new pharmaceutical product, including data from clinical trials, which must be reviewed and approved by the FDA before the product can be marketed.

A drug safety program that the FDA can require for certain medications to help ensure the benefits outweigh the risks.

An act allowing the FDA to collect fees from drug manufacturers to fund the new drug approval process, thereby accelerating reviews without compromising safety.

Regulations establishing the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

An application submitted to the FDA in order to start clinical trials on a new drug in humans. This must show safety and efficacy data from laboratory and animal studies.

An ongoing review of OTC drugs by the FDA to ensure their safety and efficacy; includes categorization in monographs.

A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.

A law aimed at preventing foodborne illnesses by shifting the focus from responding to contamination to preventing it.

Regulations that require manufacturers to ensure their products are produced consistently and in controlled conditions to ensure quality.

The center within the FDA responsible for regulating biological products for human use.

The most serious type of recall issued by the FDA, where there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

A law that aims to protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful by enabling track and trace across the supply chain.