The final rule formalizes the general procedures the FDA will follow when evaluating PMTAs including application acceptance, filing and inspections. The finalized rule also outlines how companies can submit application amendments, the time for review, withdraws of applications, postmarket reporting requirements for those that receive marketing granted orders, FDA communications with the applicant and the agency’s disclosure procedures and electronic submission requirements. The FDA also explains how applicants can submit supplemental PMTA or resubmission and what information won’t need to be resubmitted.
For the SE final rule, the FDA details the content and format of the SE reports in an effort to make the filing process more efficient. The agency also details how it will retain records related to SE reports, how confidentiality will be handled, how applicants can transfer ownership of an SE report to a new applicant, how amendments can be made and how SE reports can be submitted electronically.
The FDA’s final rule for the Premarket Tobacco Product Applications (PMTA) can be found here, while the final rule for Substantial Equivalence (SE) reports can be found here.
For all the latest news from the FDA, visit fda.gov.