Tag: FDA requirements
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Medication Guides are FDA-mandated safety documents for high-risk prescription drugs. Pharmacists and providers must distribute them correctly-when, how, and to whom. Learn the legal requirements, common mistakes, and how to stay compliant.
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The FDA requires generic drug manufacturers to prove bioequivalence through clinical studies showing their product delivers the same amount of medicine at the same rate as the brand-name version. This ensures safety and effectiveness.
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- bioequivalence
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