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Access this article Similar content being viewed by others Data availability The materials and the resources used were provided by Maharshi Dayanand University, Rohtak, and Haryana

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doi: 10.1007/s00204-024-03941-w 98 LaiQLiuF-MRaoW-LYuanG-YFanZ-YZhangLet al

You developed written procedures that failed to ensure that you, and your contractor acting on your behalf, complied with all applicable PADE regulations for the surveillance, receipt, evaluation, and reporting of ADEs, the letter stated