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process ensuring a product's safety and effectiveness for public use

FDA approval is the process by which the U.S. Food and Drug Administration (FDA) formally evaluates and authorizes a product, such as a medication or medical device, for public use based on evidence of its safety, efficacy, and quality. This rigorous process involves multiple phases of clinical trials and extensive review of data to ensure that the benefits of the product outweigh any potential risks.

Related Terms

• regulatory approval
• clinical trials
• drug approval process
• Regulatory Approval
• FDA registration
• FDA Adverse Event Reporting System
• Food and Drug Administration
• FDA-approved
• Drug Approval Process
• Off-label Use