AB69-ASA1-AA2,2,2
6“(c) During the time an eligible patient is using an investigational drug, device,
7or biological product as provided in this section, the manufacturer shall notify the
8treating physician and the eligible patient of any clinically significant finding of a
9known or anticipated risk, side effect, or reported patient discomfort that is likely
10related to the investigational drug, device, or biological product that becomes known
1to the manufacturer after the eligible patient begins using the investigational drug,
2device, or biological product.”.
