Ubiotica Corp. v. Food and Drug Administration

427 F.2d 376 (1970)

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Ubiotica Corp. v. Food and Drug Administration

United States Court of Appeals for the Sixth Circuit
427 F.2d 376 (1970)

AR

Facts

Ubiotica Corp. (plaintiff) submitted a new-drug application to the Food and Drug Administration (FDA). The FDA refused to approve the new drug because its investigation found that Ubiotica had failed to show that the drug was safe and effective for its intended use. Ubiotica appealed the decision to the United States Court of Appeals for the Sixth Circuit.

Rule of Law

Issue

Holding and Reasoning (Combs, J.)

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Casebooks

Food and Drug Law

Key Terms