FDA Cracks Down on Unapproved HCT Products
In FY 2020, FDA issued nearly two dozen warning letters and untitled letters to human cell and tissue product (HCT/P) manufacturers marketing products they claim will treat various diseases and life-threatening conditions—including cancer, amyotrophic lateral sclerosis, Alzheimer’s, autism, arthritis, stroke, multiple sclerosis, macular degeneration, Parkinson’s disease, chronic obstructive pulmonary disease (COPD), and many others—without proof […]