The applications failed to meet the agency's requirements for protecting the public health. Read More
Tags :Marketing Denial Order
The company expects Bidi Stick sales to rebound in the wake of the ruling. Read More
Uncertainty lingers as the FDA decides the fate of the remaining marketing applications. Read More
The company’s application has been placed back into the PMTA review process.Read More
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
