Marketing authorization

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Marketing authorization or marketing approval is issued from a therapy regulatory agency that allows a therapy to be placed on the market, i.e. to be manufactured and sold outside a research setting. A regulatory authority may specify requirements for quality, safety, and efficacy to be demonstrated for a product before granting marketing authorization and may have additional requirements to keep the product on the market. The U.S. Food and Drug Administration (FDA) is the regulatory agency in the United States.

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U.S. Food and Drug Administration (FDA): What We Do
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NCATS Toolkit for Patient-Focused Therapy Development: FDA Review and Approval

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