Charles E. Binkley, MD, Michael S. Politz, MA, and Brian P. Green, PhD
If the safe-and-effective standard for judging devices’ potential as therapy or enhancement is inadequate, one might wonder whether BCI regulation should be overseen by the FDA.
AMA J Ethics. 2021;23(9):E745-749. doi:
10.1001/amajethics.2021.745.
Pharma has long marketed opioids in ways that contribute to opioid use disorder and deaths by overdose. Regulatory mistakes in approving and labeling new analgesics by the FDA didn’t make us safer.
AMA J Ethics. 2020;22(8):E743-750. doi:
10.1001/amajethics.2020.743.
Pharmacologic interventions might help physicians overcome cognitive deficits resulting from loss of sleep while on call or help them retain more details about the patients under their care.