FDA CTP’s Public Meeting on PTMAs updated stakeholders on a variety of issues pertaining Premarket Tobacco Product Applications for Deemed Products, including items such as scientific content ensuring applications and information contained are Appropriate for the Protection of Public Health (APPH). FDA reviews chemistry, microbiology, toxicology and more and applicants must ensure establishments referenced in a PMTA submission are “inspection ready” at the time of submission. In addition to chemistry, microbiology and toxicology, FDA will observe the manufacturing process for the proposed APPH product ensuring compliance with FDA-regulated facility Current Good Manufacturing Practice (cGMP) inspection per sections 902 and 906(e)(1) of the FD&C Act. Learn more in FDLI’s Update where Tara Couch, Ph.D., Senior Director for Dietary Supplements and Tobacco Products, co-authored a meeting summary.
Posted in EAS in Action, EASeNews, Tobacco.