FDA Plans to Launch New CTP Web Portal for Tobacco Product Applications

The Center for Tobacco Products (CTP) of the US Food and Drug Administration (FDA) plans to launch a new generation CTP web portal next year for submitting new tobacco product applications. The goal is to integrate major Substantial Equivalence (SE) reports and Premarket Tobacco Product Applications (PMTAs), previously submitted amendments, and general correspondence into one system, simplify the submission process by consolidating PDF editing software, FDA's eSubmitter desktop tool, and FDA's CTP Portal web application, and provide tools for expediting data entry. Existing CTP Portal accounts and pending or ongoing applications will automatically migrate to the new CTP Portal Next Generation. The CTP will provide additional communication and support before the changes take effect. Two Federal Register notices are seeking public input on entering SE and PMTA information, with the public comment period starting on July 16 and ending on September 14.