Stakeholders now have until Oct. 6 to share their thoughts on the proposed FDA rule. Read More
The meeting will be a hybrid event, with the option to attend virtually. Read More
The company did not demonstrate that the product’s benefit outweighs the risks. Read More
Tobacco Control Act allows FDA to require manufacturers submit comparative health risk data.Read More
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Second Circuit Appeals Court Rules for FDA
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
