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The regulatory scheme for approving pharmaceutical products before they can be sold has long put drug manufacturers at odds with regulators at the Food and Drug Administration. One of the more contentious issues between drug developers and the FDA involves the length of time it typically takes the FDA to approve an application for a new drug. A case now pending in federal court in Washington brings this very issue to a head, as Sandoz Inc., frustrated by not having received a decision from the FDA on a new drug application (NDA) after more than two years, has sued to force the FDA to act.

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