The FDA used questionable statistics to justify its marketing denial, says Neil McKeganey.Read More
Tags :Marketing Denial Order
The firm believes the marketing denial was substantively and procedurally flawed. Read More
The FDA and the company are saying different things about Magellan’s application. Read More
The FDA never conducted a scientific review of its PMTA, says vaping company. Read More
The FDA’s approach was both reasoned and consistent with the law, according to ruling. Read More
The FDA’s refusal to review marketing plans was error and not harmless (disagreeing with Fifth and DC Circuits).Read More
The e-cigarette manufacturer waited too long to file its emergency motion, says court.Read More
But the FDA denied authorization to several other 'Daily' products. Read More
The R.J. Reynolds Vapor Company's top selling Alto device is still under PMTA review; an update is expected soon.Read More
The applications failed to meet the agency's requirements for protecting the public health. Read More
