regenerative medicine

FDA & Autologous Medicine

The FDA fires a shot across the bow of the regenerative medicine industry with three new draft guidance documents.
FDA & Autologous  Medicine

The U.S. Food and Drug Administration (FDA) is a federal agency with incredibly broad jurisdiction. For the past 100 years, the FDA’s jurisdiction has frequently expanded to the point where it now regulates nearly one-fifth of the U.S. economy, and directly impacts the lives of the American people every day. In the past 20 years, the FDA has expanded its jurisdiction into the regulation of the regenerative medicine industry and, specifically, medical treatment involving the use of a patient’s autologous cells and tissues.