FDA Drug Approval Document

An FDA Drug Approval Document is an official report issued by the U.S. Food and Drug Administration that confirms a medication has been reviewed and meets safety, efficacy, and manufacturing quality standards. It details the evidence from clinical trials showing the drug's benefits and risks, explains how it works, and outlines how it should be used. This document ensures that healthcare providers and patients have reliable information about the drug before it becomes available on the market, helping to promote safe and effective treatment options.