FDA-approved

What approval involves

Before a new drug can be sold, its maker runs laboratory and animal studies and then clinical trials in people. The FDA generally expects at least two well-designed trials showing real benefit, though one may be enough for a rare disease.

A team at the FDA's Center for Drug Evaluation and Research then reviews the data and the proposed label. The FDA doesn't test the drug itself. It judges whether the company's evidence holds up and whether the label accurately describes benefits, risks and dosing. Some drugs also get a Risk Evaluation and Mitigation Strategy (REMS) to manage specific dangers.

Approval is tied to a specific use

Approval covers a particular drug, made a particular way, for particular conditions and doses. That's why the same molecule can be approved under one brand for diabetes and another brand for weight management. Using an approved drug for something outside its label is called off-label use, which is legal and common but isn't covered by the approval itself.

Generic drugs and biosimilars are also FDA-approved, after showing they match the original product closely enough.

What the FDA does not approve

The phrase 'FDA-approved' is often stretched. These are not FDA-approved:

• Compounded drugs, including compounded versions of brand-name medicines.
• Dietary supplements, which can be sold without FDA review of safety or effectiveness.
• Most medical devices. Moderate-risk devices are 'cleared,' not approved; only high-risk Class III devices are approved.
• Cosmetics, apart from their color additives.
• Health care providers, laboratories and manufacturing facilities. Being registered or inspected is not the same as being approved.

How to check

You can look up approved drugs in the FDA's Drugs@FDA database, and the label (prescribing information) for most approved drugs is posted on DailyMed. If a product says it's 'made in an FDA-registered facility,' that tells you where it was made, not that the product itself was approved.

On HealifyMD, each treatment page states whether the medication is FDA-approved, compounded, or an approved drug used off-label.

Approval also isn't the end of the FDA's involvement. After a drug is on the market, the agency keeps collecting reports of side effects, can require label changes and new warnings, and sometimes asks for further studies. A label you read today may include safety information that wasn't known when the drug was first approved.