January 23, 2021

The Niche

Trusted stem cell blog & resources

FDA interstate commerce

3 min read

The FDA’s mandate to regulate drugs and devices often invokes a term called “interstate commerce”. Like many people I thought I knew what that meant, but probably like most people I was wrong. After a great discussion on an original post on various key issues related to the many stem cell clinics doing non-FDA approved stem cell “treatments”, the question came up as to whether the FDA has any authority over a biological product if the manufacturer does not introduce it into “interstate commerce” …Read More