The company is still seeking a judicial stay pending the outcome of its lawsuit. Read More
Tags : Marketing Denial Order
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
The agency’s recent decision covers a fraction of products under review, say critics. Read More
The products must be removed from the market or risk enforcement.Read More
