Is product liability the same as insurance for an FDA-regulated clinical investigation?
Do not assume so. For an FDA-regulated investigation under an IND, identify the sponsor and your company’s role, then ask a specialist to compare study duties, participant events, and product allegations with the proposed forms.
Read the study protocol and agreement together. Mark who selects participants, performs procedures, monitors outcomes, handles records, and controls the product.1,2
Read the Therapeutics Insurance Buying Guide
Sources and Further Reading for Therapeutics
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