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All this has already been accomplished by the original manufacturer, and was subsequently reflected in the brand-name drug price.

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The generic drug approval process has been reviewed (Welage et al., 2001) for scientific issues related to the approval course of. In 1984, the Drug Worth Competitors and Patent Term Restoration Act gave the FDA statutory authority to approve generic versions of innovator drug products accredited after 1962 as secure and efficient (Henderson, 1992).
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