Stem cell manufacturers have rarely been subject to aggressive US FDA enforcement actions, but Commissioner Scott Gottlieb's recent announcement about a crackdown on unscrupulous companies in the regenerative medicine industry along with the seizure of product from a California facility could signal a meaningful change in how the agency targets dishonest industry players, a former FDAer says.
The Center for Biologics Evaluation and Research (CBER) has not often directed the seizure of unapproved product as it did...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?