The Food and Drug Administration, regenerative sciences, and the regulation of autologous stem cell therapies.

In an ongoing dispute, FDA asserts that autologous cultured stem cells used in treatments for orthopedic conditions are drugs and biological products subject to licensing and good manufacturing practice requirements, while the company providing the treatments claims FDA has no authority over its activities. This article uses the dispute as a focal point to explore current issues relating to the regulation of innovative stem cell-based products, including the impact of regulation on access to new treatments, the role of other oversight mechanisms, the particular challenges of autologous stem cell products and the scope of existing flexibilities in the regulatory framework.