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Comments on the FDA’s Proposed Rule Regarding the “Intended Uses” of Marketed Drugs and Medical Devices

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Public Citizen strongly supports the Food and Drug Administration’s (FDA’s) proposal to amend the sections of its regulations that describe the types of evidence relevant to determining the intended uses of a marketed drug or medical device under the Food, Drug, and Cosmetic Act. The FDA’s authority to make such determinations is critically important to the agency’s core mission to protect public health by ensuring that all marketed drugs and medical devices are safe and effective for their intended uses.