Tips for a Successful Modified Risk Tobacco Product (MRTP) Application
Tips for a Successful Modified Risk Tobacco Product (MRTP) Application Not only does your Modified Risk Tobacco Product (MRTP) application require a great deal of scientific data, it should be organized according to the U.S. FDA’s guidelines to maximize your chances...
Evaluate Harm Reduction Potential with the ToxTracker Assay
3 Ways the ToxTracker® Assay Can Evaluate Harm Reduction Potential for Tobacco/Nicotine Products In vitro toxicology assays such as Ames, neutral red uptake, and micronucleus, are routinely used for regulatory submissions for tobacco and nicotine-containing products....
How Tobacco Manufacturers Can Prepare for an FDA Inspection
Preparing for an FDA PMTA Pre-Approval Inspection – Expert Tips for Tobacco Manufacturers FDA takes tobacco manufacturer inspections as part of the PMTA approval process seriously. These inspections are rigorous, yet a necessary part of doing business in the U.S....
How to Respond to a PMTA Deficiency Letter
Responding to a PMTA Deficiency Letter – What You Need to Know Along the pathway of gaining FDA PMTA marketing authorization, you will likely receive a PMTA deficiency letter and a request from the U.S. FDA for more information, including scientific data, about the...