CTP is offering a webpage with more in-depth information on how to complete the three required PMTA forms.Read More
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The two-day public meeting on the premarket tobacco product application process will be on Oct. 23–24.Read More
The lawmakers’ call comes after the FDA failed to meet a court-ordered deadline of Sept. 9, 2021, to complete its review.Read More
Based on the latest status report, the FDA plans to have 55 percent covered by Sept. 30. Read More
The CTP created a fact sheet to help with amending applications and a video to help navigate the CTP portal.Read More
Judges agree that the FDA changed the decision-making criteria after the PMTA submissions were made.Read More
The FDA also announced it issued a refuse-to-accept letter to a company that submitted 17 million PMTAs.Read More
The agency doesn't expect to complete PMTAs for the popular vaping products until the end of the year.Read More
The original court order required the regulatory agency to take action on PMTAs by September 2021.Read More
Morgan Stanley said it expected the rejected products to remain on the U.S. market until a court decision.Read More