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WHAT IS IT???. HOW IS IT???. WHY IS IT???. REGULATION VERSUS PHARMACEUTICAL COMP.. Facts. Generic drugs are safe and effective alternatives to brand name prescriptionsGeneric drugs can help both consumers and the government reduce the cost of prescription drugs. NDA vs. ANDA Review Process. Original DrugNDA RequirementsChemistryManufacturingControlsLabelingTestingAnimal StudiesClinical Studies(Bioavailability/Bioequivalence).

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