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§ 63-6-308. No private cause of action for harm done to eligible patient resulting from investigational drug, biological product, or device -- Part does not affect requirements under § 56-7-2365.

TN Code § 63-6-308 (2019) (N/A)
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(a) This part does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device for any harm done to the eligible patient resulting from the investigational drug, biological product, or device, if the manufacturer or other person or entity is complying in good faith with the terms of this part and has exercised reasonable care.

(b) This part does not affect any mandatory healthcare coverage for participation in clinical trials under § 56-7-2365.

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§ 63-6-309. Reporting of adverse events.