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Home / Opinion Digests / Manufacturer didn’t knowingly mislead FDA  (access required)

Manufacturer didn’t knowingly mislead FDA  (access required)

A manufacturer of allergenic extracts prevailed on its motions for summary judgment on claims under the False Claims Act, or FCA. The manufacturer did not mislabel its product; a letter it sent to the Food and Drug Administration, or FDA, was not misleading; the company was regularly inspected by the FDA, which reviewed documentation containing ...