AB69-ASA1-AA4,1,11
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 or side effect that is likely related to the investigational
10drug, device, or biological product that becomes known to the manufacturer after the
11eligible patient begins using the investigational drug, device, or biological product.”.