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==Administration, drug policy and safety== ===Drug policy=== {{Main|Drug policy}} In the [[United States]], the [[Food and Drug Administration]] (FDA) is responsible for creating guidelines for the approval and use of drugs. The FDA requires that all approved drugs fulfill two requirements: # The drug must be found to be effective against the disease for which it is seeking approval (where 'effective' means only that the drug performed better than placebo or competitors in at least two trials). # The drug must meet safety criteria by being subject to animal and controlled human testing. Gaining FDA approval usually takes several years. Testing done on animals must be extensive and must include several species to help in the evaluation of both the effectiveness and toxicity of the drug. The dosage of any drug approved for use is intended to fall within a range in which the drug produces a [[therapeutic effect]] or desired outcome.<ref name=nagle>{{cite book|last1=Nagle|first1=Hinter | first2 = Barbara | last2 = Nagle | name-list-style = vanc |title=Pharmacology: An Introduction|year=2005|publisher=[[McGraw Hill]]|location=[[Boston]]|isbn=978-0-07-312275-5}}{{pn|date=March 2025}}</ref> The safety and effectiveness of prescription drugs in the U.S. are regulated by the federal [[Prescription Drug Marketing Act (PDMA)|Prescription Drug Marketing Act of 1987]]. The [[Medicines and Healthcare products Regulatory Agency]] (MHRA) has a similar role in the UK. [[Medicare Part D]] is a prescription drug plan in the U.S. The [[Prescription Drug Marketing Act (PDMA)]] is an act related to drug policy. [[Prescription drug]]s are drugs regulated by legislation.
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