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Regulatory

FDA — What It Means in Clinical Trials

Plain English Definition

The FDA (Food and Drug Administration) is the US government agency responsible for approving new drugs, devices, and treatments. Before any new drug can be sold in the United States, it must go through FDA-reviewed clinical trials to prove it is safe and effective. The FDA also monitors drug safety after approval.

Why It Matters

When a listing says a drug is "FDA-approved," it means it has passed rigorous testing. When a drug is "investigational" or "experimental," it means the FDA has allowed it to be tested but has not yet approved it for general use.

Example

A listing might say: "This investigational drug has not been approved by the FDA for any indication." This is standard language meaning the drug is still being tested.

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