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In Short The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ( FDA ) approved license in order to ensure their products are safe for consumption. Until the FDA issued regulatory guidance in 2015, most manufacturers interpreted the FDA regulation at issue as allowing a general license for the custom mixes of extracts. But the FDA s 2015 guidance clarified that a separate license was required for custom mixes. Seizing on the guidance, relators have sought False Claims Act ( FCA ) liability for earlier claims that do not comport with the regulations as they stand today. ....
In Short The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ( FDA ) approved license in order to ensure their products are safe for consumption. Until the FDA issued regulatory guidance in 2015, most manufacturers interpreted the FDA regulation at issue as allowing a general license for the custom mixes of extracts. But the FDA s 2015 guidance clarified that a separate license was required for custom mixes. Seizing on the guidance, relators have sought False Claims Act ( FCA ) liability for earlier claims that do not comport with the regulations as they stand today. ....