An Applicants Perspective -PMTA

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 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.