Blistering Decision | Fifth Circuit Court Rebukes FDA’s PMTA Process | RegWatch (Live)
January 15, 2024 by regulatorwatch.com
Blistering Decision | Fifth Circuit Court Rebukes FDA’s PMTA Process | RegWatch (Live)
A U.S. federal appeals court issues a scathing rebuke of FDA’s authorization process for flavored nicotine vaping products, reversing marketing denial orders for two mid-sized vape manufacturers and ordering the regulator to take a fresh look at their PMTA applications.