Judges agree the FDA changed decision-making criteria after PMTA submissions were made.Read More
Tags :PMTA
To date, the agency has authorized 23 new e-cigarette products.Read More
The agency now expects to have taken action on applications by Dec. 31. Read More
Rather than conducting reviews in silo, the FDA should consider all evidence, says vape lawyer. Read More
Are choices key to successful switching?Read More
The FDA and the company are saying different things about Magellan’s application. Read More
How effective must a product be in helping adult smokers quit to overcome the theorized level of harm to youth?Read More
Neil McKeganey explains how companies can make the most of a recent ruling forcing the FDA to reconsider MDOs. Read More
A court ruling requires the agency to take a another look at six marketing applications.Read More
The FDA’s refusal to review marketing plans was error and not harmless (disagreeing with Fifth and DC Circuits).Read More
