2014 – ISSCR Press Releases and Statements

February 4 Decision Reinforces Regulatory Oversight of Stem Cell Treatments

Feb 07, 2014

The US District Court of Appeals for the DC Circuit has upheld a lower court ruling that a stem cell treatment described as a procedure falls under the authority of the US Food and Drug Administration (FDA) as a product. This sets a precedent for regulatory oversight of certain stem cell treatments as drugs or biological products in the USA. 

Read the District Court of Appeals Decision