THR advocates filed their amicus briefs in support of companies that are challenging the FDA's MDOs.Read More
Tags : marketing denial order
E-liquid manufacturers and retailers are still figuring out how to survive the FDA’s erratic regulatory rules.Read More
The decision was motivated by multiple factors over several years, including the FDA's PMTA process.Read More
Court records show the FDA failed at reviewing PMTA data as required, only seeking specific studies. Read More
The ruling creates an interesting circuit split that some experts say might attract Supreme Court interest.Read More
The company’s application has been placed back into the PMTA scientific review process.Read More
In its haste to process millions of PMTAs, the FDA took a shortcut, documents suggest. Read More
The U.S. FDA devastates small businesses with a plethora of marketing denial orders.Read More
The company is still seeking a judicial stay pending the outcome of its lawsuit. Read More
Judges say the FDA pulled a “surprise switcheroo” in changing its PMTA guidance.Read More