Second Circuit Appeals Court Rules for FDA
Magellan failed to show the product would benefit adult users outweighing youth risk.Read More
Magellan failed to show the product would benefit adult users outweighing youth risk.Read More
The FDA plans to have 100 percent of covered applications acted on by Dec. 31. Read More
CTP created a fact sheet to help amend applications and a video to help navigate the CTP portal.Read More
Judges agree the FDA changed decision-making criteria after PMTA submissions were made.Read More
The FDA said the company did not demonstrate its menthol products provide an added benefit over tobacco flavors.Read More
The application now moves on to a preliminary scientific review. Read More
The agency issues marketing denial orders to several Logic-branded products.Read More
The e-cigarette manufacturer waited too long to file its emergency motion, says court.Read More
The move follows favorable product reception in the United Kingdom. Read More
The agency also failed to consider the totality of evidence in the application, the firm said.Read More