San Francisco—Some researchers trying to improve the treatment of patients with acute ischemic stroke maintain that the regulatory and reimbursement environment is frustrating their efforts.
These investigators argue that the US Food and Drug Administration (FDA) has created unequal approval thresholds that favor new devices over new drugs. This, in turn, means that devices may become elements of the standard of care before their efficacy in improving outcomes is established.
Mitka M. Regulations, Payment Affect Stroke Research. JAMA. 2007;297(12):1304-1305. doi:10.1001/jama.297.12.1304