The company’s application has been placed back into the PMTA review process.Read More
Tags :Marketing Denial Order
In its haste to process millions of PMTAs, the FDA took a shortcut, documents suggest. Read More
Uncertainty persists even as the FDA approves an ENDS product for marketing.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
The move suggests the earlier rescission of TBP’s MDO was not a one-off. Read More
It remains unclear whether the FDA will withdraw more marketing denials.Read More
It could be some time before the FDA issues marketing orders for flavored vapor products.Read More
The company’s marketing application was not properly assessed, says FDA.Read More
The FDA issues the first warning letters following its marketing denial orders. Read More