The FDA’s authority to go after for-profit stem-cell clinics selling unproven therapies getting a federal court’s approval puts manufacturers on notice that the agency has reason to regulate them, officials and lawyers say.
At issue is how much authority the FDA has over medical treatments that manipulate fat tissue. Clinics that sell the therapy say they are surgical procedures that don’t require FDA regulations. The agency counters these companies are making unproven claims that fall under its stem-cell regulations and must be stopped because they can harm patients
The June 3 summary judgment from the U.S. District Court for the ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.