The FDA has now issued its proposed rule for pre-market
tobacco product applications (PMTA), with detailed advice and guidance on this demanding and rigorous process for applicants preparing to submit their applications.
This report provides a concise overview of the proposed rule as well as how the applications are assessed.
Key Topics Covered
Introduction
Overview of the application
Labelling and marketing
Health risk investigations
How the PMTA will be assessed
Industry concerns
Submission success
Purchase
For more information about this report visit
A Guide To The FDA's Premarket Tobacco Applications (PMTAs)
