Medical Product Innovation and Regulation: Benefits vs. Risks

Medical Product Innovation and Regulation: Benefits vs. Risks

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Description

Prior to marketing in the United States, medical products are reviewed for safety and effectiveness by the Food and Drug Administration (FDA). Medical products regulated by FDA include prescription drugs, medical devices, and biologics. During the premarket review process, FDA balances the benefits that patients may receive from using the product against the harms or risks that some patients may experience.


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