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official authorization from agencies to market a product

Regulatory approval is the official authorization granted by governmental or regulatory agencies, such as the FDA in the United States, allowing a product, such as a new medication or medical device, to be marketed and sold. This process involves rigorous evaluation of the product's safety, efficacy, and quality through clinical trials and other scientific assessments to ensure it meets the required standards for public use.

Related Terms

• Drug Approval Process
• FDA approval
• FDA-approved
• FDA registration
• Regulatory Network
• ICH Guidelines
• Off-label Use
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