The drug insert and the physician's concern.
The package insert has achieved an increasingly important role, not only as a device to communicate prescribing information to physicians, but also as a key element in the standards used to determine the liability of physicians for adverse drug reactions. Regulations recently proposed by the FDA illustrate the significance of the package insert from the governmental perspective. This paper deals with the impact of these regulations on the medical profession.
D004349:Drug Packaging / Q000592:standards*; D006801:Humans; D008318:Malpractice; D014481:United States; D014486:United States Food and Drug Administration