An Applicants Perspective -PMTA
Time: 1:45 pm - 2:00 pm
Date: May 17 2022
The preparation of a PMTA that will be sufficient to establish, to FDA’s satisfaction, that the marketing of a product is “appropriate for the protection of public health” requires careful consideration of multiple sources of FDA’s expectations and requirements for such a filing. These include guidance’s, proposed rules, formal scientific advice, PMTA workshop presentations, and… Read more »
The E-Cigarette Summit USAThe preparation of a PMTA that will be sufficient to establish, to FDA’s satisfaction, that the marketing of a product is “appropriate for the protection of public health” requires careful consideration of multiple sources of FDA’s expectations and requirements for such a filing. These include guidance’s, proposed rules, formal scientific advice, PMTA workshop presentations, and other sources. I will discuss my perspective on the challenges and opportunities that characterized my participation, on behalf of an applicant, in this important and historic process.
Speakers
- David Graham Chief Impact Officer - NJOY
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