The United States Food and Drug Administration issued a warning letter to patients in 2012 that recommended informed consent, and to researchers that approval would be required for clinical trials that seek a label claim for multiple sclerosis therapy using angioplasty balloons.
The United States Food and Drug Administration issued a warning letter to patients in 2012 that recommended informed consent, and warned that benefits are not proven. To researchers, they stated that approval would be required for clinical trials that seek a label claim for multiple sclerosis therapy using angioplasty balloons.