Tobacco Products

Tobacco Product Master Files

May 2016

This guidance provides recommendations to industry on tobacco product master files (TPMFs). TPMFs are used to permit the person that owns the TPMF (TPMF owner) to authorize other persons to rely on information in the TPMF to support a submission to FDA without the TPMF owner having to disclose that information to other persons. These files typically contain trade secret and/or confidential commercial information that the TPMF owner does not wish to make public.


 

Page Last Updated: 05/05/2016
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